Quartz II/III: A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02292719
• Collaborator: (none)
• Enrollment: 70
• Arms: 6
• Actual Duration (Months): 30.8

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV infection with or without Cirrhosis.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C Virus Infection	Drug: OBV/PTV/r; Drug: Sofosbuvir; Drug: Ribavirin (RBV)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection or Genotype 3 HCV Infection With or Without Cirrhosis
• Actual Study Start Date: Dec 19, 2014
• Actual Primary Completion Date: Jul 14, 2017
• Actual Study Completion Date: Jul 14, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A (genotype [GT]3, noncirrhotic) Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.	Drug: OBV/PTV/r; Tablet; Other Names: ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ritonavir (r) also known as Norvir VIEKIRAX combination tablets TECHNIVIE ; Drug: Sofosbuvir; Tablet; Other Names: Sovaldi
Experimental: Arm B (GT3, noncirrhotic) OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.	Drug: OBV/PTV/r; Tablet; Other Names: ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ritonavir (r) also known as Norvir VIEKIRAX combination tablets TECHNIVIE ; Drug: Sofosbuvir; Tablet; Other Names: Sovaldi ; Drug: Ribavirin (RBV); Tablet
Experimental: Arm C (GT2, noncirrhotic) OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.	Drug: OBV/PTV/r; Tablet; Other Names: ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ritonavir (r) also known as Norvir VIEKIRAX combination tablets TECHNIVIE ; Drug: Sofosbuvir; Tablet; Other Names: Sovaldi ; Drug: Ribavirin (RBV); Tablet
Experimental: Arm D (GT2, noncirrhotic) OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.	Drug: OBV/PTV/r; Tablet; Other Names: ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ritonavir (r) also known as Norvir VIEKIRAX combination tablets TECHNIVIE ; Drug: Sofosbuvir; Tablet; Other Names: Sovaldi ; Drug: Ribavirin (RBV); Tablet
Experimental: Arm E (GT3, cirrhotic) OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.	Drug: OBV/PTV/r; Tablet; Other Names: ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ritonavir (r) also known as Norvir VIEKIRAX combination tablets TECHNIVIE ; Drug: Sofosbuvir; Tablet; Other Names: Sovaldi ; Drug: Ribavirin (RBV); Tablet
Experimental: Arm F (GT3, noncirrhotic) OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.	Drug: OBV/PTV/r; Tablet; Other Names: ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ritonavir (r) also known as Norvir VIEKIRAX combination tablets TECHNIVIE ; Drug: Sofosbuvir; Tablet; Other Names: Sovaldi

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [12 weeks after the last actual dose of study drug]

   SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.

Secondary Outcome Measures

1. Percentage of Participants With On-treatment Virologic Failure [Up to Week 12]

   On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.

2. Percentage of Participants With Post-treatment Relapse [Up to 12 weeks after the last actual dose of active study drug]

   Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Chronic HCV infection prior to study enrollment.

2. Screening laboratory results from the central clinical laboratory indicating HCV genotype 2 or 3 infection only (no mixed genotype).

3. Absence OR presence of cirrhosis.

4. If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (HCC)

Exclusion Criteria:

1. Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody

2. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse.

3. Current enrollment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV therapy (other than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir, boceprevir, ABT-450, or ombitasvir (ABT-267).

4. Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.

5. Abnormal lab tests.

6. Females who are pregnant or plan to become pregnant or breastfeeding, or males whose partners are pregnant or planning to become pregnant

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Mariem Charafeddine, MD, AbbVie

Study Documents (Full-Text)

• Study Protocol - Jul 31, 2014
• Statistical Analysis Plan - Jul 12, 2017

More Information

Publications

• Shafran SD, Shaw D, Charafeddine M, Agarwal K, Foster GR, Abunimeh M, Pilot-Matias T, Pothacamury RK, Fu B, Cohen E, Cohen DE, Gane E. Efficacy and safety results of patients with HCV genotype 2 or 3 infection treated with ombitasvir/paritaprevir/ritonavir and sofosbuvir with or without ribavirin (QUARTZ II-III). J Viral Hepat. 2018 Feb;25(2):118-125. doi: 10.1111/jvh.12782. Epub 2017 Sep 14.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02292719
• Other Study ID Numbers: M14-567; 2014-003147-35
• First Posted: Nov 17, 2014
• Last Update Posted: Jul 12, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by AbbVie: Hepatitis C Virus; Genotype 2; Chronic Hepatitis C; Genotype 3; Non-cirrhotic; Cirrhotic
• Additional relevant MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Ritonavir; Ribavirin; Sofosbuvir

Study Results

Participant Flow

Pre-assignment Detail	The study included a 35-day screening period.

Arm/Group Title	Arm A (Genotype [GT]3, Noncirrhotic)	Arm B (GT3, Noncirrhotic)	Arm C (GT2, Noncirrhotic)	Arm D (GT2, Noncirrhotic)	Arm E (GT3, Cirrhotic)	Arm F (GT3, Noncirrhotic)
Arm/Group Description	Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.	OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
Period Title: Overall Study
STARTED	9	11	10	9	21	10
COMPLETED	9	11	9	8	20	10
NOT COMPLETED	0	0	1	1	1	0

Baseline Characteristics

Arm/Group Title	Arm A (Genotype [GT]3, Noncirrhotic)	Arm B (GT3, Noncirrhotic)	Arm C (GT2, Noncirrhotic)	Arm D (GT2, Noncirrhotic)	Arm E (GT3, Cirrhotic)	Arm F (GT3, Noncirrhotic)	Total
Arm/Group Description	Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.	OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.	Total of all reporting groups
Overall Participants	9	11	10	9	21	10	70
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.1 (9.17)	53.5 (8.26)	56.6 (6.70)	61.6 (5.90)	53.8 (6.56)	48.9 (7.52)	54.2 (7.88)
Sex: Female, Male (Count of Participants)
Female	4 44.4%	4 36.4%	5 50%	3 33.3%	9 42.9%	2 20%	27 38.6%
Male	5 55.6%	7 63.6%	5 50%	6 66.7%	12 57.1%	8 80%	43 61.4%
Race/Ethnicity, Customized (Count of Participants)
White	7 77.8%	11 100%	10 100%	7 77.8%	17 81%	9 90%	61 87.1%
Black or African American	0 0%	0 0%	0 0%	0 0%	1 4.8%	0 0%	1 1.4%
Asian	1 11.1%	0 0%	0 0%	2 22.2%	1 4.8%	1 10%	5 7.1%
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	2 9.5%	0 0%	2 2.9%
Native Hawaiian or other Pacific Islander	1 11.1%	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Description	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Arm A (Genotype [GT]3, Noncirrhotic)	Arm B (GT3, Noncirrhotic)	Arm C (GT2, Noncirrhotic)	Arm D (GT2, Noncirrhotic)	Arm E (GT3, Cirrhotic)	Arm F (GT3, Noncirrhotic)
Arm/Group Description	Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.	OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
Measure Participants	9	11	10	9	21	10
Number (95% Confidence Interval) [percentage of participants]	100 1111.1%	90.9 826.4%	90.0 900%	44.4 493.3%	100 476.2%	100 1000%

2. Secondary Outcome

Title	Percentage of Participants With On-treatment Virologic Failure
Description	On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.
Time Frame	Up to Week 12

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Arm A (Genotype [GT]3, Noncirrhotic)	Arm B (GT3, Noncirrhotic)	Arm C (GT2, Noncirrhotic)	Arm D (GT2, Noncirrhotic)	Arm E (GT3, Cirrhotic)	Arm F (GT3, Noncirrhotic)
Arm/Group Description	Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.	OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
Measure Participants	9	11	10	9	21	10
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

3. Secondary Outcome

Title	Percentage of Participants With Post-treatment Relapse
Description	Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Time Frame	Up to 12 weeks after the last actual dose of active study drug

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Arm A (Genotype [GT]3, Noncirrhotic)	Arm B (GT3, Noncirrhotic)	Arm C (GT2, Noncirrhotic)	Arm D (GT2, Noncirrhotic)	Arm E (GT3, Cirrhotic)	Arm F (GT3, Noncirrhotic)
Arm/Group Description	Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.	OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.	OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
Measure Participants	9	10	10	9	21	10
Number (95% Confidence Interval) [percentage of participants]	0 0%	0 0%	10.0 100%	55.6 617.8%	0 0%	0 0%

Adverse Events

Time Frame	Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
Adverse Event Reporting Description	TEAEs and and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Arm/Group Title	Arm A (Genotype [GT]3, Noncirrhotic)		Arm B (GT3, Noncirrhotic)		Arm C (GT2, Noncirrhotic)		Arm D (GT2, Noncirrhotic)		Arm E (GT3, Cirrhotic)		Arm F (GT3, Noncirrhotic)
Arm/Group Description	Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD ) and sofosbuvir (SOF) 400 mg QD for 12 weeks.		OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.		OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.		OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.		OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.		OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
All Cause Mortality
	Arm A (Genotype [GT]3, Noncirrhotic)		Arm B (GT3, Noncirrhotic)		Arm C (GT2, Noncirrhotic)		Arm D (GT2, Noncirrhotic)		Arm E (GT3, Cirrhotic)		Arm F (GT3, Noncirrhotic)
	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	0/9 (0%)		0/11 (0%)		0/10 (0%)		0/9 (0%)		0/21 (0%)		0/10 (0%)
Serious Adverse Events
	Arm A (Genotype [GT]3, Noncirrhotic)		Arm B (GT3, Noncirrhotic)		Arm C (GT2, Noncirrhotic)		Arm D (GT2, Noncirrhotic)		Arm E (GT3, Cirrhotic)		Arm F (GT3, Noncirrhotic)
	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	0/9 (0%)		0/11 (0%)		1/10 (10%)		0/9 (0%)		2/21 (9.5%)		0/10 (0%)
Blood and lymphatic system disorders
ANAEMIA	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	1/21 (4.8%)	1	0/10 (0%)	0
Infections and infestations
PNEUMONIA	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
RESPIRATORY TRACT INFECTION VIRAL	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	1/21 (4.8%)	1	0/10 (0%)	0
Other (Not Including Serious) Adverse Events
	Arm A (Genotype [GT]3, Noncirrhotic)		Arm B (GT3, Noncirrhotic)		Arm C (GT2, Noncirrhotic)		Arm D (GT2, Noncirrhotic)		Arm E (GT3, Cirrhotic)		Arm F (GT3, Noncirrhotic)
	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	8/9 (88.9%)		10/11 (90.9%)		10/10 (100%)		9/9 (100%)		20/21 (95.2%)		8/10 (80%)
Blood and lymphatic system disorders
ANAEMIA	0/9 (0%)	0	1/11 (9.1%)	1	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
Cardiac disorders
PALPITATIONS	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	0/10 (0%)	0
Ear and labyrinth disorders
HYPOACUSIS	1/9 (11.1%)	1	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
Eye disorders
DRY EYE	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
VISION BLURRED	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	1/21 (4.8%)	1	1/10 (10%)	1
Gastrointestinal disorders
ABDOMINAL DISCOMFORT	1/9 (11.1%)	1	0/11 (0%)	0	1/10 (10%)	1	1/9 (11.1%)	1	1/21 (4.8%)	1	1/10 (10%)	1
ABDOMINAL DISTENSION	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	1/9 (11.1%)	1	1/21 (4.8%)	1	1/10 (10%)	1
ABDOMINAL PAIN UPPER	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	2/21 (9.5%)	3	0/10 (0%)	0
CONSTIPATION	0/9 (0%)	0	1/11 (9.1%)	1	1/10 (10%)	1	3/9 (33.3%)	3	0/21 (0%)	0	0/10 (0%)	0
DIARRHOEA	0/9 (0%)	0	1/11 (9.1%)	1	3/10 (30%)	3	2/9 (22.2%)	2	2/21 (9.5%)	3	3/10 (30%)	3
DRY MOUTH	1/9 (11.1%)	1	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	1/10 (10%)	1
DYSPEPSIA	0/9 (0%)	0	1/11 (9.1%)	1	1/10 (10%)	1	3/9 (33.3%)	3	1/21 (4.8%)	1	0/10 (0%)	0
FLATULENCE	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	1/21 (4.8%)	1	0/10 (0%)	0
GASTROOESOPHAGEAL REFLUX DISEASE	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	1/10 (10%)	1
MOUTH ULCERATION	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	1/21 (4.8%)	1	0/10 (0%)	0
NAUSEA	0/9 (0%)	0	1/11 (9.1%)	1	3/10 (30%)	3	0/9 (0%)	0	6/21 (28.6%)	10	3/10 (30%)	3
STOMATITIS	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	0/10 (0%)	0
VOMITING	1/9 (11.1%)	1	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	1/21 (4.8%)	1	0/10 (0%)	0
General disorders
CHEST PAIN	1/9 (11.1%)	1	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	1/21 (4.8%)	1	0/10 (0%)	0
ENERGY INCREASED	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
FATIGUE	3/9 (33.3%)	3	3/11 (27.3%)	3	3/10 (30%)	4	6/9 (66.7%)	9	10/21 (47.6%)	13	4/10 (40%)	4
FEELING ABNORMAL	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	2/21 (9.5%)	2	2/10 (20%)	2
INFLUENZA LIKE ILLNESS	1/9 (11.1%)	1	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
MALAISE	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
OEDEMA PERIPHERAL	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	1/10 (10%)	1
PAIN	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	1/21 (4.8%)	1	0/10 (0%)	0
Infections and infestations
EAR INFECTION	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	2/21 (9.5%)	2	0/10 (0%)	0
GASTROENTERITIS	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
GENITAL HERPES	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
HERPES ZOSTER	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
LOWER RESPIRATORY TRACT INFECTION	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	1/10 (10%)	1
PARONYCHIA	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
RESPIRATORY TRACT INFECTION VIRAL	0/9 (0%)	0	1/11 (9.1%)	2	0/10 (0%)	0	1/9 (11.1%)	2	0/21 (0%)	0	0/10 (0%)	0
SINUSITIS	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	0/10 (0%)	0
UPPER RESPIRATORY TRACT INFECTION	0/9 (0%)	0	0/11 (0%)	0	4/10 (40%)	4	0/9 (0%)	0	5/21 (23.8%)	5	1/10 (10%)	1
URINARY TRACT INFECTION	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
VIRAL UPPER RESPIRATORY TRACT INFECTION	1/9 (11.1%)	1	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
Injury, poisoning and procedural complications
BACK INJURY	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	0/10 (0%)	0
CONTUSION	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	1/21 (4.8%)	1	1/10 (10%)	1
MUSCLE STRAIN	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	1/21 (4.8%)	1	0/10 (0%)	0
Investigations
HAEMOGLOBIN DECREASED	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	1/21 (4.8%)	1	0/10 (0%)	0
INTERNATIONAL NORMALISED RATIO DECREASED	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	0/10 (0%)	0
Metabolism and nutrition disorders
DECREASED APPETITE	1/9 (11.1%)	1	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	3/21 (14.3%)	3	2/10 (20%)	2
POLYDIPSIA	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
Musculoskeletal and connective tissue disorders
ARTHRALGIA	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	1/9 (11.1%)	1	1/21 (4.8%)	1	1/10 (10%)	1
BACK PAIN	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	2/9 (22.2%)	2	4/21 (19%)	4	0/10 (0%)	0
JOINT SWELLING	1/9 (11.1%)	1	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
MUSCLE SPASMS	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	2/9 (22.2%)	2	1/21 (4.8%)	1	0/10 (0%)	0
MUSCULOSKELETAL CHEST PAIN	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	0/10 (0%)	0
MYALGIA	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	3/21 (14.3%)	4	0/10 (0%)	0
NECK PAIN	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
PLANTAR FASCIITIS	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	1/10 (10%)	1
Nervous system disorders
DISTURBANCE IN ATTENTION	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	1/21 (4.8%)	1	1/10 (10%)	1
DIZZINESS	1/9 (11.1%)	2	1/11 (9.1%)	1	1/10 (10%)	1	2/9 (22.2%)	3	4/21 (19%)	4	2/10 (20%)	2
DYSGEUSIA	1/9 (11.1%)	1	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	1/10 (10%)	1
HEAD DISCOMFORT	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
HEADACHE	1/9 (11.1%)	1	2/11 (18.2%)	2	6/10 (60%)	8	3/9 (33.3%)	4	9/21 (42.9%)	9	2/10 (20%)	2
HYPOAESTHESIA	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	1/10 (10%)	1
INTERCOSTAL NEURALGIA	1/9 (11.1%)	1	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
MEMORY IMPAIRMENT	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	0/10 (0%)	0
PARAESTHESIA	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	1/10 (10%)	1
POOR QUALITY SLEEP	1/9 (11.1%)	1	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	0/10 (0%)	0
Psychiatric disorders
AGITATION	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	0/10 (0%)	0
ANXIETY	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	1/21 (4.8%)	2	1/10 (10%)	1
DEPRESSED MOOD	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	3	0/21 (0%)	0	0/10 (0%)	0
DEPRESSION	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	1/21 (4.8%)	1	0/10 (0%)	0
DISORIENTATION	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	0/10 (0%)	0
HALLUCINATION	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	1/10 (10%)	1
INSOMNIA	1/9 (11.1%)	1	0/11 (0%)	0	2/10 (20%)	2	0/9 (0%)	0	5/21 (23.8%)	5	1/10 (10%)	1
IRRITABILITY	1/9 (11.1%)	1	0/11 (0%)	0	1/10 (10%)	1	1/9 (11.1%)	1	1/21 (4.8%)	1	1/10 (10%)	1
MOOD SWINGS	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	1/10 (10%)	1
SLEEP DISORDER	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	1/21 (4.8%)	1	1/10 (10%)	1
TEARFULNESS	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	1/10 (10%)	1
WITHDRAWAL SYNDROME	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	0/10 (0%)	0
Renal and urinary disorders
CHROMATURIA	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	1/21 (4.8%)	1	0/10 (0%)	0
MICTURITION URGENCY	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
POLLAKIURIA	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
URINE ODOUR ABNORMAL	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA	1/9 (11.1%)	1	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
NIPPLE PAIN	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	0/10 (0%)	0
Respiratory, thoracic and mediastinal disorders
COUGH	1/9 (11.1%)	1	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	1/21 (4.8%)	1	1/10 (10%)	1
DYSPNOEA	0/9 (0%)	0	3/11 (27.3%)	3	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	0/10 (0%)	0
DYSPNOEA EXERTIONAL	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	2/21 (9.5%)	2	0/10 (0%)	0
EPISTAXIS	0/9 (0%)	0	1/11 (9.1%)	1	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
OROPHARYNGEAL PAIN	1/9 (11.1%)	1	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	1/21 (4.8%)	1	1/10 (10%)	1
RESPIRATORY TRACT CONGESTION	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	1/10 (10%)	1
UPPER RESPIRATORY TRACT CONGESTION	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	1/9 (11.1%)	1	0/21 (0%)	0	0/10 (0%)	0
Skin and subcutaneous tissue disorders
DRY SKIN	0/9 (0%)	0	1/11 (9.1%)	1	1/10 (10%)	1	0/9 (0%)	0	1/21 (4.8%)	1	1/10 (10%)	1
ECZEMA	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	1/21 (4.8%)	1	0/10 (0%)	0
INGROWING NAIL	0/9 (0%)	0	0/11 (0%)	0	2/10 (20%)	2	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
NIGHT SWEATS	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
PRURITUS	1/9 (11.1%)	1	2/11 (18.2%)	3	0/10 (0%)	0	2/9 (22.2%)	2	7/21 (33.3%)	7	1/10 (10%)	1
PRURITUS ALLERGIC	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
PRURITUS GENERALISED	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	2/21 (9.5%)	2	1/10 (10%)	1
PSORIASIS	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
RASH	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	4/21 (19%)	4	1/10 (10%)	1
RASH ERYTHEMATOUS	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	2/21 (9.5%)	2	0/10 (0%)	0
RASH PRURITIC	0/9 (0%)	0	0/11 (0%)	0	0/10 (0%)	0	0/9 (0%)	0	3/21 (14.3%)	3	0/10 (0%)	0
SKIN ODOUR ABNORMAL	0/9 (0%)	0	1/11 (9.1%)	1	0/10 (0%)	0	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
SKIN ULCER	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0
Vascular disorders
HOT FLUSH	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	1/10 (10%)	1
PERIPHERAL ARTERY STENOSIS	0/9 (0%)	0	0/11 (0%)	0	1/10 (10%)	1	0/9 (0%)	0	0/21 (0%)	0	0/10 (0%)	0

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.