Trial · NCT01485991
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy
NCT01485991, Phase 3, Completed, Janssen R&D Ireland; results first posted 2015-04-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy. Trials, record NCT01485991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01485991
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy
- NCT number
- NCT01485991
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 771 participants, actual
- Lead sponsor
- Janssen R&D Ireland
- Conditions
- Hepatitis C
- Interventions
- TMC435, TVR
- First posted
- 2011-12-06
- Last updated
- 2016-04-26
- Results first posted
- 2015-04-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) | 12 Weeks After the Planned End of Treatment (EOT: Week 48) | Participants are considered to have reached SVR12 if both conditions below are met: 1) HCV RNA levels less than (\<) 25 International unit per milliliter (IU/mL) undetectable; 2) HCV RNA levels \<25 IU/mL undetectable or HCV RNA levels \<25 IU/mL detectable. |
| Secondary | Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24) | 24 Weeks After the Planned EOT (Week 48) | Participants are considered to have reached SVR24 if both conditions below are met: 1) HCV RNA levels less than \<25 International unit per milliliter (IU/mL) undetectable (at the actual end of treatment);2) HCV RNA levels \<25 IU/mL undetectable or HCV RNA levels \<25 IU/mL detectable (24 weeks after the planned EOT). |
| Secondary | Percentage of Participants With Viral Relapse | End of Treatment (Week 48) up to Follow-up Period (until Week 72) | Participants are considered to have a viral relapse if both conditions as specified are met: 1) \<25 IU/mL undetectable HCV RNA at the actual end of study drug treatment; 2) confirmed HCV RNA greater than or equal to (\>=) 25 IU/mL during follow-up. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) | 12 Weeks After the Planned End of Treatment (EOT: Week 48) | Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24) | 24 Weeks After the Planned EOT (Week 48) | ITT population included all randomized participants who took at least 1 dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Viral Relapse | End of Treatment (Week 48) up to Follow-up Period (until Week 72) | ITT population included all randomized participants who took at least 1 dose of study drug. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 53.6 | percentage of participants | ||
| Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 54.7 | percentage of participants | ||
| Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24) | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 53.3 | percentage of participants | ||
| Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24) | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 55.2 | percentage of participants | ||
| Percentage of Participants With Viral Relapse | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 17.9 | percentage of participants | ||
| Percentage of Participants With Viral Relapse | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 16.4 | percentage of participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 385 | |
| Overall Study | STARTED | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 386 | |
| Overall Study | Treated | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 379 | |
| Overall Study | Treated | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 384 | |
| Overall Study | COMPLETED | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 353 | |
| Overall Study | COMPLETED | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 350 | |
| Overall Study | NOT COMPLETED | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 32 | |
| Overall Study | NOT COMPLETED | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 36 |
Source ClinicalTrials.gov
Adverse events238
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 132 | 379 | |
| other | Fatigue | General disorders | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 155 | 384 | |
| other | Pyrexia | General disorders | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 86 | 379 | |
| other | Pyrexia | General disorders | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 101 | 384 | |
| other | Asthenia | General disorders | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 80 | 379 | |
| other | Asthenia | General disorders | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 69 | 384 | |
| other | Influenza like illness | General disorders | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 64 | 379 | |
| other | Influenza like illness | General disorders | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 66 | 384 | |
| other | Chills | General disorders | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 22 | 379 | |
| other | Chills | General disorders | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 40 | 384 |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | ||
| Total, all-cause mortality | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | ||
| Total, other adverse events | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 349 | 379 |
| Total, other adverse events | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 369 | 384 |
| Total, serious adverse events | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 22 | 379 |
| Total, serious adverse events | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 54 | 384 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25482330 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin vs Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01485991
GET https://conductscience.org/api/trials/v1/NCT01485991/events?page=2