A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01672983
• Collaborator: (none)
• Enrollment: 110
• Arms: 6
• Duration (Months): 22

Study Details

Study Description

Brief Summary

This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b) or genotype 2 (HCV GT2) infection who were previous treated with pegylated interferon/ribavirin (pegIFN/RBV).

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C Infection	Drug: ABT-450/ritonavir, ABT-267	Phase 2

Detailed Description

This multicenter, randomized, open-label, parallel-arm, combination treatment study consisted of a Treatment and Post-treatment Phase, divided into 2 cohorts: 1) chronic HCV GT1b- infected, pegIFN/RBV treatment-exposed Japanese adults; and 2) HCV GT2-infected, pegIFN/RBV treatment-exposed Japanese adults. The Treatment Phase evaluated the antiviral activity, safety, and pharmacokinetics of a range of ABT-450/r and ABT-267 doses for 12 to 24 weeks. The Post-treatment Phase evaluated the evolution and persistence of viral resistance to ABT-267 and ABT-450.

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study to Evaluate the Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Drug: ABT-450/ritonavir, ABT-267; ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet); Other Names: ABT-450 also known as paritaprevir ABT-267 also known as ombitasvir ritonavir also known as Norvir ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 2 Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Drug: ABT-450/ritonavir, ABT-267; ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet); Other Names: ABT-450 also known as paritaprevir ABT-267 also known as ombitasvir ritonavir also known as Norvir ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 3 Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Drug: ABT-450/ritonavir, ABT-267; ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet); Other Names: ABT-450 also known as paritaprevir ABT-267 also known as ombitasvir ritonavir also known as Norvir ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 4 Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Drug: ABT-450/ritonavir, ABT-267; ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet); Other Names: ABT-450 also known as paritaprevir ABT-267 also known as ombitasvir ritonavir also known as Norvir ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 5 Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Drug: ABT-450/ritonavir, ABT-267; ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet); Other Names: ABT-450 also known as paritaprevir ABT-267 also known as ombitasvir ritonavir also known as Norvir ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets
Experimental: Arm 6 Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Drug: ABT-450/ritonavir, ABT-267; ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet); Other Names: ABT-450 also known as paritaprevir ABT-267 also known as ombitasvir ritonavir also known as Norvir ABT/450/r/ABT-267 (ABT-450 coformulated with ritonavir and ABT-267) also known as VIEKIRAX Combination Tablets

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24) [24 weeks after last dose of study drug]

   The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.

2. Number of Participants With Adverse Events (AEs) [TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.]

   An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.

Secondary Outcome Measures

1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) [12 weeks after last dose of study drug]

   The percentage of participants with SVR12 (plasma HCV RNA level < LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.

2. Percentage of Participants With End of Treatment (EOT) Response [12 or 24 weeks after first dose of study drug]

   The percentage of participants with EOT response (plasma HCV RNA level < LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile

• Chronic hepatitis C, genotype 1b (HCV-GT1b) or genotype 2 (HCV GT2) infection (HCV RNA level greater than 10,000 IU/mL at screening) previously treated with pegylated interferon/ribavirin (pegIFN/RBV).

• Subject's hepatitis C virus genotype is subgenotype 1b and subject was a null responder or partial responder, OR

• Subject's hepatitis C virus genotype is subgenotype 2 and subject was a null responder, partial responder, or relapser (Null responder: received at least 10 weeks of pegIFN/RBV for the treatment of HCV and failed to achieve a 2 log10 IU/mL reduction in HCV RNA at Week 12; Partial responders: received at least 20 weeks of pegIFN/RBV for the treatment of HCV and achieved ≥ 2 log10 IU/mL reduction in HCV RNA at Week 12, but failed to achieve HCV RNA undetectable (HCV RNA < lower limit of detection [< LLOD]) at the end of treatment; Relapsers: received at least 1 course of pegIFN/RBV for the treatment of HCV and was undetectable at the end of treatment, but HCV RNA was detectable within 24 weeks of treatment follow-up).

Exclusion Criteria:

• Significant liver disease with any cause other than HCV as the primary cause

• Positive screen for drugs or alcohol.

• Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.

• Use of contraindicated medications within 2 weeks of dosing

• Previous use of any investigational or commercially available anti-Hepatitis C virus agent other than pegIFN/RBV, including previous exposure to ABT-450 or ABT-267.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Takuma Matsuda, MS, AbbVie GK.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01672983
• Other Study ID Numbers: M12-536
• First Posted: Aug 27, 2012
• Last Update Posted: May 30, 2018
• Last Verified: Oct 1, 2015

• Keywords provided by AbbVie (prior sponsor, Abbott): Japanese; Hepatitis C; Genotype 2; Genotype 1b; paritaprevir; ombitasvir; ritonavir; VIEKIRAX Combination Tablets
• Additional relevant MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic; Ritonavir

Study Results

Participant Flow

Arm/Group Title	Arm 1	Arm 2	Arm 3	Arm 4	Arm 5	Arm 6
Arm/Group Description	Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Period Title: Overall Study
STARTED	18	18	19	18	19	18
Completed Study Drug	18	17	18	18	12	17
COMPLETED	18	18	19	18	19	18
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Arm 1	Arm 2	Arm 3	Arm 4	Arm 5	Arm 6	Total
Arm/Group Description	Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Total of all reporting groups
Overall Participants	18	18	19	18	19	18	110
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.3 (15.06)	54.8 (11.96)	61.9 (8.14)	57.5 (10.15)	62.5 (8.34)	62.8 (7.89)	59.2 (10.84)
Sex: Female, Male (Count of Participants)
Female	8 44.4%	7 38.9%	12 63.2%	10 55.6%	12 63.2%	10 55.6%	59 53.6%
Male	10 55.6%	11 61.1%	7 36.8%	8 44.4%	7 36.8%	8 44.4%	51 46.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)
Description	The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.
Time Frame	24 weeks after last dose of study drug

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: all subjects who received at least 1 dose of study drug

Arm/Group Title	Arm 1	Arm 2	Arm 3	Arm 4	Arm 5	Arm 6
Arm/Group Description	Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Measure Participants	18	18	19	18	19	18
Number (95% Confidence Interval) [percentage of participants]	100 555.6%	88.9 493.9%	100 526.3%	100 555.6%	57.9 304.7%	72.2 401.1%

2. Primary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.
Time Frame	TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.

Outcome Measure Data

Analysis Population Description

Safety population: all participants who received at least 1 dose of study drug

Arm/Group Title	Arm 1 + Arm 5	Arm 2 + Arm 6	Arm 3	Arm 4
Arm/Group Description	Arm 1: Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks; Arm 5: Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Arm 2: Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks; Arm 6: Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
Measure Participants	37	36	19	18
Adverse Events	28 155.6%	31 172.2%	16 84.2%	15 83.3%
Serious Adverse Events	1 5.6%	2 11.1%	2 10.5%	0 0%

3. Secondary Outcome

Title	Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12)
Description	The percentage of participants with SVR12 (plasma HCV RNA level < LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.
Time Frame	12 weeks after last dose of study drug

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Arm 1	Arm 2	Arm 3	Arm 4	Arm 5	Arm 6
Arm/Group Description	Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.	Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.	Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 24 weeks.	Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 24 weeks.	Hepatitis C Virus (HCV), genotype 2 (GT2) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.	Hepatitis C Virus (HCV), genotype 2 (GT2) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
Measure Participants	18	18	19	18	19	18
Number (95% Confidence Interval) [percentage of participants]	100 555.6%	88.9 493.9%	100 526.3%	100 555.6%	57.9 304.7%	72.2 401.1%

4. Secondary Outcome

Title	Percentage of Participants With End of Treatment (EOT) Response
Description	The percentage of participants with EOT response (plasma HCV RNA level < LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL.
Time Frame	12 or 24 weeks after first dose of study drug

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Arm 1	Arm 2	Arm 3	Arm 4	Arm 5	Arm 6
Arm/Group Description	Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.	Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.	Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
Measure Participants	18	18	19	18	19	18
Number (95% Confidence Interval) [percentage of participants]	100 555.6%	100 555.6%	100 526.3%	100 555.6%	63.2 332.6%	83.3 462.8%

Adverse Events

Time Frame	Treatment-emergent AEs (TEAEs) were collected from first dose of study drug administration to 30 days after last dose (up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (total up to 77 weeks).
Adverse Event Reporting Description	TEAEs were collected from the first dose of study drug to 30 days after last dose (12-week treatment: up to 16 weeks; 24-week treatment: up to 28 weeks); SAEs were collected from the time that informed consent was obtained to 30 days after last dose (12-week treatment: total up to 65 weeks; 24-week treatment: total up to 77 weeks).
Arm/Group Title	Arm 1		Arm 2		Arm 3		Arm 4		Arm 5		Arm 6
Arm/Group Description	Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.		Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.		Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.		Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.		Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.		Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
All Cause Mortality
	Arm 1		Arm 2		Arm 3		Arm 4		Arm 5		Arm 6
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1		Arm 2		Arm 3		Arm 4		Arm 5		Arm 6
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		2/18 (11.1%)		2/19 (10.5%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
Gastrointestinal disorders
COLITIS ISCHAEMIC	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
Hepatobiliary disorders
AUTOIMMUNE HEPATITIS	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
Injury, poisoning and procedural complications
FEMUR FRACTURE	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
TIBIA FRACTURE	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
Metabolism and nutrition disorders
FLUID RETENTION	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1		Arm 2		Arm 3		Arm 4		Arm 5		Arm 6
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/18 (77.8%)		15/18 (83.3%)		16/19 (84.2%)		15/18 (83.3%)		14/19 (73.7%)		16/18 (88.9%)
Blood and lymphatic system disorders
HYPOCHROMIC ANAEMIA	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
LEUKOCYTOSIS	0/18 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)
LEUKOPENIA	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
NEUTROPENIA	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
NEUTROPHILIA	0/18 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)
Cardiac disorders
ATRIAL FIBRILLATION	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
PALPITATIONS	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
TACHYCARDIA	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
VENTRICULAR EXTRASYSTOLES	1/18 (5.6%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
Ear and labyrinth disorders
SUDDEN HEARING LOSS	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
Eye disorders
ASTHENOPIA	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
BLEPHARITIS	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
CHALAZION	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
CONJUNCTIVITIS	0/18 (0%)		0/18 (0%)		2/19 (10.5%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
DIPLOPIA	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
DRY EYE	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
PUNCTATE KERATITIS	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
STRABISMUS	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
Gastrointestinal disorders
ABDOMINAL DISCOMFORT	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
ABDOMINAL PAIN	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
ABDOMINAL PAIN UPPER	0/18 (0%)		1/18 (5.6%)		1/19 (5.3%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
CONSTIPATION	1/18 (5.6%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
DENTAL CARIES	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)
DIARRHOEA	3/18 (16.7%)		0/18 (0%)		1/19 (5.3%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)
DUODENAL ULCER	0/18 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)
DYSPEPSIA	2/18 (11.1%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		2/18 (11.1%)
ENTERITIS	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
ENTEROCOLITIS	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
GASTRITIS	1/18 (5.6%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
GASTROOESOPHAGEAL REFLUX DISEASE	0/18 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)
GINGIVAL PAIN	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
GLOSSODYNIA	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
NAUSEA	2/18 (11.1%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		2/19 (10.5%)		0/18 (0%)
RADICULAR CYST	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
STOMATITIS	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
VOMITING	3/18 (16.7%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
General disorders
CHEST DISCOMFORT	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
FATIGUE	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
MALAISE	2/18 (11.1%)		0/18 (0%)		1/19 (5.3%)		1/18 (5.6%)		1/19 (5.3%)		0/18 (0%)
OEDEMA	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
OEDEMA PERIPHERAL	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		2/19 (10.5%)		1/18 (5.6%)
PAIN	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
PYREXIA	1/18 (5.6%)		0/18 (0%)		2/19 (10.5%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
Hepatobiliary disorders
BILIARY COLIC	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
CHOLELITHIASIS	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)
Immune system disorders
SEASONAL ALLERGY	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		1/18 (5.6%)
Infections and infestations
BRONCHITIS	2/18 (11.1%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
CYSTITIS	0/18 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)
GASTROENTERITIS	0/18 (0%)		0/18 (0%)		2/19 (10.5%)		2/18 (11.1%)		2/19 (10.5%)		0/18 (0%)
GASTROENTERITIS BACTERIAL	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		1/18 (5.6%)
GASTROENTERITIS VIRAL	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
GINGIVITIS	0/18 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		1/18 (5.6%)
HELICOBACTER GASTRITIS	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
INFLUENZA	0/18 (0%)		0/18 (0%)		0/19 (0%)		2/18 (11.1%)		0/19 (0%)		1/18 (5.6%)
NASOPHARYNGITIS	1/18 (5.6%)		6/18 (33.3%)		4/19 (21.1%)		9/18 (50%)		5/19 (26.3%)		7/18 (38.9%)
PERIODONTITIS	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
PNEUMONIA	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
UPPER RESPIRATORY TRACT INFECTION	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
Injury, poisoning and procedural complications
ANIMAL BITE	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		2/18 (11.1%)
ARTHROPOD STING	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
CONTUSION	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
PROCEDURAL PAIN	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
Investigations
ALANINE AMINOTRANSFERASE INCREASED	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		1/18 (5.6%)
ASPARTATE AMINOTRANSFERASE INCREASED	0/18 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		1/18 (5.6%)
BLOOD ALKALINE PHOSPHATASE INCREASED	0/18 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		1/18 (5.6%)
BLOOD BILIRUBIN INCREASED	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)
BLOOD BILIRUBIN UNCONJUGATED INCREASED	1/18 (5.6%)		0/18 (0%)		1/19 (5.3%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)
BLOOD CREATININE INCREASED	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
BLOOD GLUCOSE INCREASED	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
BLOOD PRESSURE INCREASED	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		1/18 (5.6%)
CREATININE RENAL CLEARANCE DECREASED	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
HAEMOGLOBIN DECREASED	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
LYMPHOCYTE COUNT DECREASED	0/18 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)
NEUTROPHIL COUNT DECREASED	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
PROTEIN URINE PRESENT	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
URINE LEUKOCYTE ESTERASE POSITIVE	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
WHITE BLOOD CELL COUNT DECREASED	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
Metabolism and nutrition disorders
DECREASED APPETITE	1/18 (5.6%)		1/18 (5.6%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
DIABETES MELLITUS	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
HYPERLIPIDAEMIA	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
HYPOKALAEMIA	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	0/18 (0%)		1/18 (5.6%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
BACK PAIN	3/18 (16.7%)		1/18 (5.6%)		2/19 (10.5%)		2/18 (11.1%)		0/19 (0%)		0/18 (0%)
FLANK PAIN	0/18 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)
INTERVERTEBRAL DISC PROTRUSION	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
JOINT SWELLING	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
MUSCLE SPASMS	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		2/19 (10.5%)		0/18 (0%)
MUSCULOSKELETAL STIFFNESS	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
MYALGIA	2/18 (11.1%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
MYOFASCIAL PAIN SYNDROME	0/18 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)
SPINAL OSTEOARTHRITIS	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
Nervous system disorders
AUTONOMIC NERVOUS SYSTEM IMBALANCE	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
CERVICAL RADICULOPATHY	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
DIZZINESS	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		1/18 (5.6%)
HEAD DISCOMFORT	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
HEADACHE	2/18 (11.1%)		1/18 (5.6%)		3/19 (15.8%)		1/18 (5.6%)		3/19 (15.8%)		5/18 (27.8%)
MIGRAINE	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
SOMNOLENCE	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		2/19 (10.5%)		0/18 (0%)
Psychiatric disorders
DEPRESSION	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
DYSPHORIA	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
INSOMNIA	0/18 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		1/18 (5.6%)
Renal and urinary disorders
HAEMATURIA	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
NOCTURIA	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
PROTEINURIA	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
Respiratory, thoracic and mediastinal disorders
COUGH	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
OROPHARYNGEAL DISCOMFORT	0/18 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		1/19 (5.3%)		0/18 (0%)
OROPHARYNGEAL PAIN	0/18 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)
UPPER RESPIRATORY TRACT INFLAMMATION	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
Skin and subcutaneous tissue disorders
ALOPECIA AREATA	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
CUTANEOUS LUPUS ERYTHEMATOSUS	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
DERMATITIS	0/18 (0%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)		1/19 (5.3%)		0/18 (0%)
DERMATITIS ALLERGIC	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
ECZEMA	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		2/19 (10.5%)		1/18 (5.6%)
ERYTHEMA	0/18 (0%)		0/18 (0%)		0/19 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)
HYPERHIDROSIS	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
PRURITUS	1/18 (5.6%)		1/18 (5.6%)		1/19 (5.3%)		1/18 (5.6%)		1/19 (5.3%)		1/18 (5.6%)
RASH	0/18 (0%)		0/18 (0%)		2/19 (10.5%)		3/18 (16.7%)		0/19 (0%)		1/18 (5.6%)
SKIN EXFOLIATION	1/18 (5.6%)		0/18 (0%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
Vascular disorders
DEEP VEIN THROMBOSIS	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
HOT FLUSH	0/18 (0%)		1/18 (5.6%)		0/19 (0%)		0/18 (0%)		0/19 (0%)		0/18 (0%)
HYPERTENSION	1/18 (5.6%)		2/18 (11.1%)		2/19 (10.5%)		1/18 (5.6%)		1/19 (5.3%)		1/18 (5.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.