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Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

NCT01314261 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2018-07-02

Study results available
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Summary

The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected participants.

Conditions

  • Chronic Hepatitis C
  • Hepatitis C Virus (HCV) Infection

Interventions

DRUG

ABT-267

5 mg or 25 mg tablets

DRUG

Pegylated interferon (pegIFN)

Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly

DRUG

Ribavirin (RBV)

200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day

OTHER

Placebo for ABT-267

Participants received matching placebo tablet at each dose level for ABT-267.

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Armen Asatryan, MD · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-01-31
Completion
2013-02-28

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01314261 on ClinicalTrials.gov