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NCT01314261 · ClinicalTrials.gov registry record · Phase 2
Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
A Phase 2 study, sponsored by AbbVie (prior sponsor, Abbott).
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT01314261: Completed Phase 2 study, sponsored by AbbVie (prior sponsor, Abbott).
NCT01314261 is a Phase 2 study that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01314261, a Phase 2 study, has completed, sponsored by AbbVie (prior sponsor, Abbott).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study 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.
Primary Outcome
Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Rapid virologic response was defined as HCV RNA levels \< the lower limit of detection (\< 15 IU/mL) at Week 4. Data are reported as percentage of participants with RVR.
Interventions
- DRUG Ribavirin (RBV)
- DRUG ABT-267
- DRUG Pegylated interferon (pegIFN)
- OTHER Placebo for ABT-267
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-02 |
| Phase | Phase 2 |
What the finished NCT01314261 record still lists
NCT01314261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 4 interventions - of which Ribavirin (RBV) is the first listed.
NCT01314261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01314261 about?
NCT01314261 is a clinical study titled "Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects". 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 naï...
What is the current status of trial NCT01314261?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2011-03. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01314261?
The interventions under investigation include: Ribavirin (RBV) (DRUG), ABT-267 (DRUG), Pegylated interferon (pegIFN) (DRUG), Placebo for ABT-267 (OTHER).
Who is sponsoring clinical trial NCT01314261?
This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01314261's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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