Trial · NCT00627926

A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)

NCT00627926, Phase 3, Completed, Vertex Pharmaceuticals Incorporated; results first posted 2011-07-21

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV). Trials, record NCT00627926. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00627926

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
NCT number: NCT00627926
Status: Completed
Phases: Phase 3
Enrollment: 1,095 participants, actual
Lead sponsor: Vertex Pharmaceuticals Incorporated
Conditions: Hepatitis C
Interventions: Pegylated Interferon Alfa 2a, Telaprevir, Ribavirin, Placebo
First posted: 2008-03-04
Last updated: 2014-08-08
Results first posted: 2011-07-21

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment	24 weeks after last planned dose of study treatment (up to Week 72)	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidance (snapshot analysis): undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.
Secondary	Number of Subjects With Undetectable HCV RNA at Week 72	Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks)	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Secondary	Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment	Week 4	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.
Secondary	Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12	Week 4 and Week 12	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both Week 4 and Week 12.
Secondary	Number of Subjects With Undetectable HCV RNA at Week 12	Week 12	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Secondary	Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)	End of treatment (up to Week 48)	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Secondary	Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment	12 weeks after last planned dose of study treatment (up to Week 60)	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Secondary	Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment	24 weeks after last actual dose of study treatment (up to Week 72)	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
Secondary	Number of Subjects With Viral Relapse Planned and Viral Relapse Actual	After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)	Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. For viral relapse, 2 analyses were performed: planned and actual. The planned analyses was measured from the end of treatment (EOT) visit to 24 weeks after the last planned dose of study treatment. The actual analyses was measured from the EOT visit to 24 weeks after the last actual dose of study treatment.
Secondary	Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels	Baseline up to Week 48	Criteria for grading severity (toxicity) of ALT and AST: Grade 0 (\<1.25\upper limit of normal \[ULN\]); Grade 1 (mild=1.25 to 2.5\ULN); Grade 2 (moderate=2.6 to 5.0\ULN); Grade 3 (severe= greater than 5.0 to 20.0\ULN); Grade 4 (life-threatening= greater than 20.0\*ULN). Number of subjects with Grade 3 shift (from Grade 0, Grade 1 or Grade 2 baseline) and Grade 4 shift (from Grade 0, Grade 1, Grade 2 or Grade 3 baseline) are reported. If a subject experienced more than 1 severity grade shifts during post baseline assessments, the maximum severity grade shift was considered.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Number of Subjects With Undetectable HCV RNA at Week 72	Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks)	The FA set included all randomized subjects who received at least 1 dose of any study drug.	participants	NUMBER
SECONDARY	Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment	Week 4	The FA set included all randomized subjects who received at least 1 dose of any study drug.	participants	NUMBER
SECONDARY	Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12	Week 4 and Week 12	The FA set included all randomized subjects who received at least 1 dose of any study drug.	participants	NUMBER
SECONDARY	Number of Subjects With Undetectable HCV RNA at Week 12	Week 12	The FA set included all randomized subjects who received at least 1 dose of any study drug.	participants	NUMBER
SECONDARY	Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)	End of treatment (up to Week 48)	The FA set included all randomized subjects who received at least 1 dose of any study drug.	participants	NUMBER
SECONDARY	Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment	12 weeks after last planned dose of study treatment (up to Week 60)	The FA set included all randomized subjects who received at least 1 dose of any study drug.	participants	NUMBER
SECONDARY	Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment	24 weeks after last actual dose of study treatment (up to Week 72)	The FA set included all randomized subjects who received at least 1 dose of any study drug.	participants	NUMBER
SECONDARY	Number of Subjects With Viral Relapse Planned and Viral Relapse Actual	After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)	Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).	participants	NUMBER
SECONDARY	Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels	Baseline up to Week 48	The FA set included all randomized subjects who received at least 1 dose of any study drug.	participants	NUMBER
SECONDARY	Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis	Baseline through 24 weeks after last planned dose of study treatment (up to Week 72)	The FA set included all randomized subjects who received at least 1 dose of any study drug. Here number of participants analyzed signifies those subjects who were evaluable for FibroTest Analysis and n signifies those subjects who were evaluable for FibroTest Analysis in specified category for each treatment arm, respectively.	participants	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group78

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Subjects With Undetectable HCV RNA at Week 72	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	158	participants
Number of Subjects With Undetectable HCV RNA at Week 72	Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	243	participants
Number of Subjects With Undetectable HCV RNA at Week 72	Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	265	participants
Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	34	participants
Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment	Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	242	participants
Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment	Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	246	participants
Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	29	participants
Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12	Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	207	participants
Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12	Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	212	participants
Number of Subjects With Undetectable HCV RNA at Week 12	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	146	participants

1 to 10 of 78Source ClinicalTrials.gov

See all 78 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	361
Overall Study	STARTED	Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	364
Overall Study	STARTED	Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	363
Overall Study	COMPLETED	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	202
Overall Study	COMPLETED	Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	260
Overall Study	COMPLETED	Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	268
Overall Study	NOT COMPLETED	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	159
Overall Study	NOT COMPLETED	Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	104
Overall Study	NOT COMPLETED	Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	95

Source ClinicalTrials.gov

Adverse events417

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
other	fatigue	General disorders	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	206	361
other	fatigue	General disorders	Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	211	364
other	fatigue	General disorders	Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	207	363
other	influenza like illness	General disorders	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	101	361
other	influenza like illness	General disorders	Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	105	364
other	influenza like illness	General disorders	Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	102	363
other	pyrexia	General disorders	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	87	361
other	pyrexia	General disorders	Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	108	364
other	pyrexia	General disorders	Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	95	363
other	irritability	General disorders	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	64	361

1 to 10 of 417Source ClinicalTrials.gov

See all 417 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
Total, all-cause mortality	Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Total, all-cause mortality	Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Total, other adverse events	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	354	361
Total, other adverse events	Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	362	364
Total, other adverse events	Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	361	363
Total, serious adverse events	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	24	361
Total, serious adverse events	Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	31	364
Total, serious adverse events	Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week	33	363

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21696307	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00627926

GET https://conductscience.org/api/trials/v1/NCT00627926/results?page=2

API reference For AI assistants