A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

This study has been completed.

Sponsor:

Collaborator:

Tibotec Pharmaceutical Limited

Information provided by (Responsible Party):

Tibotec BVBA

ClinicalTrials.gov Identifier:

NCT00703118

First received: June 19, 2008

Last updated: December 5, 2013

Last verified: December 2013

History of Changes

Results First Received: July 18, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Hepatitis C, Chronic
Interventions:	Drug: Telaprevir Drug: Peg-IFN-alfa-2a Drug: Ribavirin Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 105 sites in 17 countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Switzerland, Germany, Spain, France, United Kingdom, Israel, Italy, Netherlands, Poland, Sweden, and the United States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
662 participants were treated (266 participants in the T12/PR48 group, 264 participants in the T12(DS)/PR48 group, and 132 participants in the Pbo/PR48 group) in this study.

Reporting Groups

	Description
T12/PR48	12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
T12(DS)/PR48	4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Pbo/PR48	48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses

Participant Flow: Overall Study

	T12/PR48	T12(DS)/PR48	Pbo/PR48
STARTED	266	264	132
COMPLETED	245	248	110
NOT COMPLETED	21	16	22
Adverse Event	1	2	2
Subject Ineligible To Continue The Trial	6	3	2
Lost to Follow-up	6	4	4
Withdrawal by Subject	8	7	13
Not specified	0	0	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
T12/PR48	12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
T12(DS)/PR48	4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Pbo/PR48	48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Total	Total of all reporting groups

Baseline Measures

	T12/PR48	T12(DS)/PR48	Pbo/PR48	Total
Number of Participants [units: participants]	266	264	132	662
Age [units: years] Mean (Standard Deviation)	50.7 (8.51)	51 (8.24)	49.9 (9.74)	50.6 (8.66)
Gender [units: participants]
Female	83	75	44	202
Male	183	189	88	460
Race/Ethnicity, Customized [units: Participants]
Asian	6	2	3	11
Black or African American	11	8	11	30
White	246	252	117	615
Other	3	2	1	6
AgeCategoricalOther [units: participants]
>= 45 years	64	55	40	159
Between 45 and 65 years	197	201	85	483
>= 65 years	5	8	7	20

Outcome Measures

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1. Primary:

Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned [ Time Frame: Week 72 ]

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2. Secondary:

Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4 [ Time Frame: Week 4 ]

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Measure Type	Secondary
Measure Title	Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4
Measure Description	RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.
Time Frame	Week 4
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.

Reporting Groups

	Description
T12/PR48	12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
T12(DS)/PR48	4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
Pbo/PR48	48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses

Measured Values

	T12/PR48	T12(DS)/PR48	Pbo/PR48
Number of Participants Analyzed [units: participants]	266	264	132
Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4 [units: Participants]	152	188	3

No statistical analysis provided for Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4

3. Secondary:

Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment) [ Time Frame: Week 48 ]

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4. Secondary:

Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned [ Time Frame: Week 60 ]

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5. Secondary:

Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8 [ Time Frame: Week 4, Week 6, or Week 8 ]

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6. Secondary:

Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72) [ Time Frame: Up to Week 72 ]

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7. Secondary:

Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 [ Time Frame: Baseline (Day 1) to Week 4 ]

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8. Secondary:

Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12 [ Time Frame: Week 4 and Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Medical Leader
Organization: Tibotec
phone: 1 609 730-3174

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zeuzem S, DeMasi R, Baldini A, Coate B, Luo D, Mrus J, Witek J. Risk factors predictive of anemia development during telaprevir plus peginterferon/ribavirin therapy in treatment-experienced patients. J Hepatol. 2014 Jun;60(6):1112-7. doi: 10.1016/j.jhep.2014.01.013. Epub 2014 Jan 29.

Younossi Z, Negro F, Serfaty L, Pol S, Diago M, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Focaccia R, Foster GR, Horban A, Lonjon-Domanec I, Coate B, DeMasi R, Picchio G, Witek J. Homeostasis model assessment of insulin resistance does not seem to predict response to telaprevir in chronic hepatitis C in the REALIZE trial. Hepatology. 2013 Dec;58(6):1897-906. doi: 10.1002/hep.26437. Epub 2013 Oct 17.

Pol S, Aerssens J, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Younossi Z, Foster GR, Focaccia R, Horban A, Pockros PJ, Van Heeswijk RP, De Meyer S, Luo D, Botfield M, Beumont M, Picchio G. Limited impact of IL28B genotype on response rates in telaprevir-treated patients with prior treatment failure. J Hepatol. 2013 May;58(5):883-9. doi: 10.1016/j.jhep.2012.12.023. Epub 2013 Jan 12.

Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Müllhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.

Responsible Party:	Tibotec BVBA
ClinicalTrials.gov Identifier:	NCT00703118 History of Changes
Other Study ID Numbers:	CR014842 VX-950-TIDP24-C216 ( Other Identifier: Tibotec-Virco Virology BVBA )
Study First Received:	June 19, 2008
Results First Received:	July 18, 2011
Last Updated:	December 5, 2013
Health Authority:	United States: Food and Drug Administration Great Britain: Medicines and Healthcare Products Regulatory Agency United States: Federal Government

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