Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection
Public ClinicalTrials.gov record NCT01132313. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety, Antiviral Effect and Pharmacokinetics of BI 207127 in Combination With BI 201335 and With or Without Ribavirin for 4, 16, 24, 28 or 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (Randomized Phase Ib/II)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating. The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV. A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa. This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3. Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)
Study identification
- NCT ID
- NCT01132313
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 488 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2010
- Primary completion
- Sep 30, 2014
- Completion
- Sep 30, 2014
- Last update posted
- Jan 31, 2016
2010 – 2014
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1241.21.0003 Boehringer Ingelheim Investigational Site | La Jolla | California | — | — |
| 1241.21.0006 Boehringer Ingelheim Investigational Site | San Diego | California | — | — |
| 1241.21.0004 Boehringer Ingelheim Investigational Site | San Francisco | California | — | — |
| 1241.21.0011 Boehringer Ingelheim Investigational Site | Palm Harbor | Florida | — | — |
| 1241.21.0013 Boehringer Ingelheim Investigational Site | Valparaiso | Indiana | — | — |
| 1241.21.0008 Boehringer Ingelheim Investigational Site | Springfield | Massachusetts | — | — |
| 1241.21.0019 Boehringer Ingelheim Investigational Site | Fayetteville | North Carolina | — | — |
| 1241.21.0012 Boehringer Ingelheim Investigational Site | Arlington | Texas | — | — |
| 1241.21.0005 Boehringer Ingelheim Investigational Site | Austin | Texas | — | — |
| 1241.21.0007 Boehringer Ingelheim Investigational Site | Dallas | Texas | — | — |
| 1241.21.0010 Boehringer Ingelheim Investigational Site | Houston | Texas | — | — |
| 1241.21.0017 Boehringer Ingelheim Investigational Site | Seattle | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01132313, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 31, 2016 · Synced Sep 16, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01132313 live on ClinicalTrials.gov.