Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01330316 · ClinicalTrials.gov registry record · Phase 3

A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

A Phase 3 study of Hepatitis C, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
119
Enrollment target
20
Study locations

NCT01330316: Completed Phase 3 study of Hepatitis C, sponsored by Boehringer Ingelheim.

NCT01330316 is a Phase 3 study of Hepatitis C that has completed, run by Boehringer Ingelheim. The registered enrollment target is 119 participants, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01330316, a Phase 3 study of Hepatitis C, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
119 participants
Enrollment target
20
Study locations

Study Summary

The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.

Primary Outcome

The primary endpoint was SVR12, defined as a plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.

Conditions Studied

Hepatitis C

Interventions

  • DRUG PegIFN/RBV
  • DRUG BI 201335

Study Locations (20)

Texas

  • 1220.48.0063 Boehringer Ingelheim Investigational Site - Arlington
  • 1220.48.0029 Boehringer Ingelheim Investigational Site - Austin
  • 1220.48.0017 Boehringer Ingelheim Investigational Site - Dallas
  • 1220.48.0071 Boehringer Ingelheim Investigational Site - Dallas
  • 1220.48.0081 Boehringer Ingelheim Investigational Site - Forth Worth

California

  • 1220.48.0011 Boehringer Ingelheim Investigational Site - Los Angeles
  • 1220.48.0018 Boehringer Ingelheim Investigational Site - Oceanside

Florida

  • 1220.48.0078 Boehringer Ingelheim Investigational Site - Fort Lauderdale
  • 1220.48.0095 Boehringer Ingelheim Investigational Site - Palm Harbor

Massachusetts

  • 1220.48.0027 Boehringer Ingelheim Investigational Site - Framingham
  • 1220.48.0065 Boehringer Ingelheim Investigational Site - Springfield

Alabama

  • 1220.48.0004 Boehringer Ingelheim Investigational Site - Birmingham

Arkansas

  • 1220.48.0091 Boehringer Ingelheim Investigational Site - North Little Rock

Georgia

  • 1220.48.0039 Boehringer Ingelheim Investigational Site - Columbus

Illinois

  • 1220.48.0013 Boehringer Ingelheim Investigational Site - Chicago

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2011-07
Est. Completion 2014-06
Phase Phase 3
Boehringer Ingelheim

515 total trials

What the finished NCT01330316 record still lists

NCT01330316 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 2 interventions - of which PegIFN/RBV is the first listed.

NCT01330316 names 20 study sites across 13 states, led by Texas, California, Florida.

Frequently Asked Questions

What is clinical trial NCT01330316 about?

NCT01330316 is a clinical study titled "A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients". The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatmen...

What is the current status of trial NCT01330316?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2011-07. Estimated completion is 2014-06.

What conditions does trial NCT01330316 study?

This clinical trial studies the following conditions: Hepatitis C.

What interventions are being tested in trial NCT01330316?

The interventions under investigation include: PegIFN/RBV (DRUG), BI 201335 (DRUG).

Who is sponsoring clinical trial NCT01330316?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01330316 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Hepatitis C

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01330316's enrollment target sits among peer trials

119 50th of 106 higher than 57 of 106 other Hepatitis C trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatitis C 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04870762 · 119 participants · Phase 2

    Customized 3D Printed Oral Stents During Head and Neck Radiotherapy

  • NCT05559853 · 119 participants

    Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment

  • NCT06564389 · 119 participants · Phase 1

    FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients

  • NCT06742801 · 119 participants · NA

    Onyx™ Liquid Embolic IDE Clinical Study

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Related registry views

Source: ClinicalTrials.gov NCT01330316, the US trial registry maintained by the National Library of Medicine. NCT01330316 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.