NCT00980330|CompletedPhase 2ResultsDMC

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

Tibotec Pharmaceuticals, Ireland ClinicalTrials.gov

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3 other identifiers

CR016063TMC435-TiDP16-C2062009-010590-20

Study Type

interventional

Target

463

Locations

13 countries

Sites

Timeline

RegisteredSep 2009

StartedOct 2009

CompletionAug 2011

Brief Summary

The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

463

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2009

Geographic Reach

13 countries

77 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

September 10, 2009

Completed

11 days until next milestone

First Posted

Study publicly available on registry

September 21, 2009

Completed

10 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed

2.5 years until next milestone

Results Posted

Study results publicly available

February 6, 2014

Completed

Last Updated

June 9, 2014

Status Verified

May 1, 2014

Enrollment Period

1.8 years

First QC Date

September 10, 2009

Results QC Date

December 18, 2013

Last Update Submit

May 30, 2014

Conditions

Hepatitis C

Keywords

Hepatitis CPeginterferon alpha-2aPegIFNalpha-2aRBVRibavirinPlaceboTMC435-TIDP16-C206TMC435-C206TMC435HCV

Outcome Measures

Primary Outcomes (1)

The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)
The table below shows the percentage of participants in the overall population with an SVR24, defined as having plasma levels of Hepatitis C Virus ribonucleic acid less than 25 IU/mL undetectable at the EOT and 24 weeks after the EOT.
Week 72

Secondary Outcomes (12)

The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment
Weeks, 2, 4, 8, and 12
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up
Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72 and EOT (up to Week 48)
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up
Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)
The Percentage of Participants Achieving a Rapid Virologic Response (RVR)
Week 4
The Percentage of Participants Achieving an Early Virologic Response (EVR)
Week 12
+7 more secondary outcomes

Study Arms (7)

TMC435 100 mg 12 Wks + PR48

EXPERIMENTAL

Participants will receive TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.