Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00107653 · ClinicalTrials.gov registry record · Phase 4
Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 569
- Enrollment target
NCT00107653: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00107653 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 569 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00107653, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 569 participants
- Enrollment target
Study Summary
This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.
Primary Outcome
Sustained Virologic Response (SVR) is defined as percentage of participants with an undetectable hepatitis C virus-RNA (HCV-RNA) measurement (\<28 International Unit (IU)/millilitre (mL)) assessed 24 weeks post-treatment (week 72) which was assessed by Roche High Pure System/COBAS TaqMan HCV Test.
Interventions
- DRUG Ribavirin
- DRUG Peginterferon alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 569 participants |
| Start Date | 2004-10 |
| Est. Completion | 2007-09 |
| Phase | Phase 4 |
What the finished NCT00107653 record still lists
NCT00107653 is an interventional study that assigns participants to a tested intervention. The registered 569 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 2 interventions - of which Ribavirin is the first listed.
NCT00107653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00107653 about?
NCT00107653 is a clinical study titled "Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.". This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months...
What is the current status of trial NCT00107653?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 569 participants. The study started on 2004-10. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00107653?
The interventions under investigation include: Ribavirin (DRUG), Peginterferon alfa-2a (DRUG).
Who is sponsoring clinical trial NCT00107653?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00107653's enrollment target sits among peer trials
569 150th of 2000 higher than 1,851 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
- NCT05000645 · 570 participants · NA
Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women
- NCT06239844 · 570 participants · NA
Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English
- NCT06701903 · 570 participants · Phase 2
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
- NCT07266831 · 570 participants · Phase 2
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
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