A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02068222
• Collaborator: (none)
• Enrollment: 10
• Arm: 1
• Duration (Months): 11

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C; Hepatitis C Virus	Drug: ABT-450/ritonavir (r); Drug: ABT-530; Drug: Ribavirin (RBV)	Phase 2

Detailed Description

Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 Chronic Hepatitis C Virus (HCV) Infection
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT-450/r and ABT-530 plus RBV ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.	Drug: ABT-450/ritonavir (r); Tablet; Other Names: ABT-450 also known as paritaprevir ; Drug: ABT-530; Tablet; Other Names: pibrentasvir ; Drug: Ribavirin (RBV); Tablet

Outcome Measures

Primary Outcome Measures

1. The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12) [12 weeks after last dose of study drug]

   SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.

Secondary Outcome Measures

1. The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24) [24 weeks after last dose of study drug]

   SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.

2. The Percentage of Subjects With Virologic Failure During Treatment [Up to Treatment Week 12]

   Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment.

3. The Percentage of Subjects With Post-Treatment Relapse [Within 12 weeks after the last dose of study drug]

   Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to <38 kg/m2.

• Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV.

• Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.

• Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.

Exclusion Criteria:

• History of severe, life-threatening or other significant sensitivity to any drug.

• Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).

• Prior therapy for the treatment of HCV.

• Any current or past clinical evidence of cirrhosis.

• Any cause of liver disease other than chronic HCV-infection.

• HCV genotype co-infection with any other HCV genotype.

• Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Armen Asatryan, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02068222
• Other Study ID Numbers: M14-213
• First Posted: Feb 21, 2014
• Last Update Posted: Feb 22, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by AbbVie: Hepatitis C; HCV; Interferon Free; Chronic Hepatitis C; Hepatitis C virus; Hepatitis C Genotype 3
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Ritonavir; Ribavirin

Study Results

Participant Flow

Arm/Group Title	ABT-450/r and ABT-530 Plus RBV
Arm/Group Description	ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. ABT-450/ritonavir (r): Tablet ABT-530: Tablet Ribavirin (RBV): Tablet
Period Title: Overall Study
STARTED	10
COMPLETED	9
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	ABT-450/r and ABT-530 Plus RBV
Arm/Group Description	ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. ABT-450/ritonavir (r): Tablet ABT-530: Tablet Ribavirin (RBV): Tablet
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.5 (10.19)
Sex: Female, Male (Count of Participants)
Female	2 20%
Male	8 80%

Outcome Measures

1. Primary Outcome

Title	The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)
Description	SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Time Frame	12 weeks after last dose of study drug

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ABT-450/r and ABT-530 Plus RBV
Arm/Group Description	ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. ABT-450/ritonavir (r): Tablet ABT-530: Tablet Ribavirin (RBV): Tablet
Measure Participants	10
Number (95% Confidence Interval) [percentage of participants]	90 900%

2. Secondary Outcome

Title	The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)
Description	SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.
Time Frame	24 weeks after last dose of study drug

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ABT-450/r and ABT-530 Plus RBV
Arm/Group Description	ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. ABT-450/ritonavir (r): Tablet ABT-530: Tablet Ribavirin (RBV): Tablet
Measure Participants	10
Number (95% Confidence Interval) [percentage of participants]	90 900%

3. Secondary Outcome

Title	The Percentage of Subjects With Virologic Failure During Treatment
Description	Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment.
Time Frame	Up to Treatment Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ABT-450/r and ABT-530 Plus RBV
Arm/Group Description	ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. ABT-450/ritonavir (r): Tablet ABT-530: Tablet Ribavirin (RBV): Tablet
Measure Participants	10
Number (95% Confidence Interval) [percentage of participants]	10 100%

4. Secondary Outcome

Title	The Percentage of Subjects With Post-Treatment Relapse
Description	Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment.
Time Frame	Within 12 weeks after the last dose of study drug

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ABT-450/r and ABT-530 Plus RBV
Arm/Group Description	ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. ABT-450/ritonavir (r): Tablet ABT-530: Tablet Ribavirin (RBV): Tablet
Measure Participants	9
Number (95% Confidence Interval) [percentage of participants]	0 0%

Adverse Events

Time Frame	Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16.5 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained through end of study (up to 41 weeks).
Adverse Event Reporting Description	Treatment-emergent adverse events are defined as any adverse event (AE) with an onset date that is after the first dose of study drug and no more than 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
Arm/Group Title	ABT-450/r and ABT-530 Plus RBV
Arm/Group Description	ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
All Cause Mortality
	ABT-450/r and ABT-530 Plus RBV
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	ABT-450/r and ABT-530 Plus RBV
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	ABT-450/r and ABT-530 Plus RBV
	Affected / at Risk (%)	# Events
Total	9/10 (90%)
Blood and lymphatic system disorders
ANAEMIA	1/10 (10%)
Eye disorders
DRY EYE	1/10 (10%)
Gastrointestinal disorders
DIARRHOEA	1/10 (10%)
FAECES SOFT	1/10 (10%)
NAUSEA	2/10 (20%)
General disorders
CHEST DISCOMFORT	1/10 (10%)
FATIGUE	4/10 (40%)
MALAISE	1/10 (10%)
PAIN	1/10 (10%)
PYREXIA	1/10 (10%)
THIRST	1/10 (10%)
Infections and infestations
ACARODERMATITIS	1/10 (10%)
ORAL HERPES	1/10 (10%)
RHINITIS	1/10 (10%)
Injury, poisoning and procedural complications
LIMB INJURY	1/10 (10%)
Investigations
BLOOD BILIRUBIN INCREASED	1/10 (10%)
HAEMOGLOBIN DECREASED	1/10 (10%)
Metabolism and nutrition disorders
ABNORMAL LOSS OF WEIGHT	1/10 (10%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	1/10 (10%)
MYALGIA	2/10 (20%)
PAIN IN EXTREMITY	1/10 (10%)
Nervous system disorders
BALANCE DISORDER	1/10 (10%)
DIZZINESS	2/10 (20%)
HEADACHE	1/10 (10%)
SYNCOPE	1/10 (10%)
Psychiatric disorders
DEPRESSION	1/10 (10%)
INSOMNIA	1/10 (10%)
IRRITABILITY	1/10 (10%)
Respiratory, thoracic and mediastinal disorders
DYSPNOEA	3/10 (30%)
OROPHARYNGEAL PAIN	1/10 (10%)
Skin and subcutaneous tissue disorders
PRURITUS	1/10 (10%)
RASH	2/10 (20%)

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.