Last reviewed · How we verify
NCT00144469
A Phase III Study of Ro25-8310 (Peginterferon Alfa-2a) in Combination With Ro20-9963 (Ribavirin) in Patients With Chronic Hepatitis C
Phase 3 trial testing peginterferon alfa-2a in Chronic Hepatitis C in 300 participants. Completed in 1 March 2005.
Quick facts
| Lead sponsor | Chugai Pharmaceutical |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 1 May 2002 |
| Estimated completion | 1 March 2005 |
Drugs / interventions tested
- peginterferon alfa-2a (PEGINTERFERON ALFA-2A) — full drug profile →
- rivavirin — full drug profile →
Conditions studied
- Chronic Hepatitis C — all drugs for Chronic Hepatitis C →
Sponsor
Chugai Pharmaceutical — full company profile →
Who can join
20 and older, any sex, with Chronic Hepatitis C. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).
Sponsor's own description
This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with peginterferon alfa-2a monotherapy. Additionally, the study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous conventional-interferon based therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00144469
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Hepatitis C
Currently open trials in the same condition.
- NCT06180590 — The Efficacy of Vosevi in Treating DAA-experienced Patients · recruiting
- NCT03993925 — Enhancing Access to Care for Chronic Hepatitis C Infected Populations in Hong Kong · active not recruiting
Other Chugai Pharmaceutical trials
Trials by the same sponsor.
- NCT07239336 — Study of DONQ52 in Active Celiac Disease · Phase 2 · recruiting
- NCT07107490 — A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER · Phase 1 · recruiting
- NCT07030959 — Study of AUBE00 in Patients With Solid Tumors · Phase 1 · recruiting
- NCT06723106 — Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial) · Phase 1 · enrolling by invitation
- NCT06371417 — Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00144469 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chugai Pharmaceutical
- Last refreshed: 29 January 2009
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00144469.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing