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NCT01830127 · ClinicalTrials.gov registry record · Phase 2
BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT01830127: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT01830127 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01830127, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).
Primary Outcome
Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.
Interventions
- DRUG Ribavirin
- DRUG Faldaprevir
- DRUG BI 207127 high dose
- DRUG BI 207127 low dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT01830127 record still lists
NCT01830127 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 4 interventions - of which Ribavirin is the first listed.
NCT01830127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01830127 about?
NCT01830127 is a clinical study titled "BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3". To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected pa...
What is the current status of trial NCT01830127?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2013-04. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01830127?
The interventions under investigation include: Ribavirin (DRUG), Faldaprevir (DRUG), BI 207127 high dose (DRUG), BI 207127 low dose (DRUG).
Who is sponsoring clinical trial NCT01830127?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01830127's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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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