Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
Chronic Hepatitis C, Hepatitis C Virus (HCV) Infection
About this trial
This is an interventional treatment trial for Chronic Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- Treatment naïve participants
- Females must be either postmenopausal for at least 2 years or surgically sterile
- Males must be surgically sterile or practicing specific forms of birth control
- Chronic hepatitis C virus (HCV), genotype-1 infected participants
- Documented FibroTest score in combination with an Aspartate Aminotransferase to Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document absence of cirrhosis
Exclusion Criteria:
- Pregnant or breastfeeding female
- Use of any medications contraindicated for use with pegylated interferon(pegIFN) or ribavirin (RBV) 2 weeks prior to study drug administration or 10 half-lives, whichever is longer
- Clinically significant cardiac, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness or psychiatric disease or disorder
- Current or past clinical evidence of cirrhosis or bridging fibrosis
- Abnormal screening laboratory results
Sites / Locations
- Site Reference ID/Investigator# 56623
- Site Reference ID/Investigator# 48476
- Site Reference ID/Investigator# 51345
- Site Reference ID/Investigator# 51498
- Site Reference ID/Investigator# 48473
- Site Reference ID/Investigator# 52782
- Site Reference ID/Investigator# 48471
- Site Reference ID/Investigator# 48474
- Site Reference ID/Investigator# 48477
- Site Reference ID/Investigator# 48472
- Site Reference ID/Investigator# 48483
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
ABT-267 (5 mg) once daily + pegIFN/RBV
ABT-267 (50 mg) once daily + pegIFN/RBV
ABT-267 (200 mg) once daily + pegIFN/RBV
Placebo + pegIFN/RBV
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.