Completed PHASE2 INTERVENTIONAL 7-arm NCT00980330

A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment (ASPIRE)

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including PegIFNa-2a and Ribavirin in HCV Genotype 1 Infected Subjects Who Failed Previous Standard Therapy

Sponsor: Tibotec Pharmaceuticals, Ireland

Conditions Hepatitis C

Interventions Peg-IFN-alfa-2a (P) Placebo Ribavirin (R) TMC435

Updated 7 times since 2017 Last updated: May 30, 2014 Started: Oct 31, 2009 Primary completion: Aug 31, 2011 Completion: Aug 31, 2011

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00980330, this PHASE2 trial focuses on Hepatitis C and remains completed. Sponsored by Tibotec Pharmaceuticals, Ireland, it has been updated 7 times since 2009, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Oct 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Tibotec Pharmaceuticals, Ireland

Data source: Tibotec Pharmaceuticals, Ireland

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Auckland, New Zealand , Berlin, Germany , Bialystok, Poland , Bruges, Belgium , Brussels, Belgium , Bydgoszcz, Poland , Calgary, Canada , Chapel Hill, United States , Chicago, United States , Christchurch, New Zealand and 68 more locations