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NCT01563536 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects
A Phase 2 study, sponsored by AbbVie (prior sponsor, Abbott).
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01563536: Completed Phase 2 study, sponsored by AbbVie (prior sponsor, Abbott).
NCT01563536 is a Phase 2 study that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01563536, a Phase 2 study, has completed, sponsored by AbbVie (prior sponsor, Abbott).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir) administered as two-day monotherapy followed by ABT-267 in combination therapy with other direct-acting antiviral agents (DAAs) ABT-450 with ritonavir (ABT-450/r) and ABT-333 (also known as dasabuvir) plus ribavirin (RBV) in patients with chronic Hepatitis C virus (HCV) infection without cirrhosis.
Primary Outcome
Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was estimated using noncompartmental analyses.
Interventions
- DRUG Ritonavir
- DRUG Ribavirin
- DRUG ABT-450
- DRUG ABT-333
- DRUG ABT-267
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT01563536 record still lists
NCT01563536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 5 interventions - of which Ritonavir is the first listed.
NCT01563536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01563536 about?
NCT01563536 is a clinical study titled "Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects". The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir) administered as two-day monotherapy followed by ABT-267 in combination therapy with other direct-acting antiviral agents (DAAs)...
What is the current status of trial NCT01563536?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2012-02. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01563536?
The interventions under investigation include: Ritonavir (DRUG), Ribavirin (DRUG), ABT-450 (DRUG), ABT-333 (DRUG), ABT-267 (DRUG).
Who is sponsoring clinical trial NCT01563536?
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 NCT01563536's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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