A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C

This study has been completed.

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00394277

First received: October 30, 2006

Last updated: July 30, 2010

Last verified: July 2010

History of Changes

Results First Received: May 27, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Factorial Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Hepatitis C, Chronic
Interventions:	Drug: peginterferon alfa-2a Drug: Ribavirin

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
PEG-IFN 180 µg + Ribavirin 1200 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 180 µg + Ribavirin 1400/1600 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
PEG-IFN 360/180 µg + Ribavirin 1200 mg	PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg	PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.

Participant Flow: Overall Study

	PEG-IFN 180 µg + Ribavirin 1200 mg	PEG-IFN 180 µg + Ribavirin 1400/1600 mg	PEG-IFN 360/180 µg + Ribavirin 1200 mg	PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
STARTED	195	196	393	391
COMPLETED	137	136	273	266
NOT COMPLETED	58	60	120	125

Baseline Characteristics

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Reporting Groups

	Description
PEG-IFN 180 µg + Ribavirin 1200 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 180 µg + Ribavirin 1400/1600 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
PEG-IFN 360/180 µg + Ribavirin 1200 mg	PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg	PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
Total	Total of all reporting groups

Baseline Measures

	PEG-IFN 180 µg + Ribavirin 1200 mg	PEG-IFN 180 µg + Ribavirin 1400/1600 mg	PEG-IFN 360/180 µg + Ribavirin 1200 mg	PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg	Total
Number of Participants [units: participants]	195	196	393	391	1175
Age ^[1] [units: years] Mean ± Standard Deviation	46.1 ± 9.86	45.1 ± 9.50	45.7 ± 9.64	46.0 ± 10.18	45.7 ± 9.83
Gender ^[1] [units: Patients]
Female	37	41	90	73	241
Male	154	148	292	310	904

[1]	Intent-to-treat population (all patients treated with at least one dose of either study medication) PEG-IFN 180 µg + Ribavirin 1200 mg: n = 191 PEG-IFN 180 µg + Ribavirin 1400/1600 mg: n = 189 PEG-IFN 360/180 µg + Ribavirin 1200 mg: n = 382 PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg: n = 383

Outcome Measures

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1. Primary:

Sustained Virological Response (SVR)-24 (Scheduled Treatment Period) [ Time Frame: Week 72 ]

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2. Secondary:

SVR-24 (Actual Treatment Period) [ Time Frame: 24 weeks after end of treatment ]

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3. Secondary:

SVR-12 (Scheduled Treatment Period) [ Time Frame: 12 weeks after end of treatment ]

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4. Secondary:

SVR-12 (Actual Treatment Period) [ Time Frame: 12 weeks after end of treatment ]

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Serious Adverse Events

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Other Adverse Events

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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. Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590

No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Reddy KR, Shiffman ML, Rodriguez-Torres M, Cheinquer H, Abdurakhmanov D, Bakulin I, Morozov V, Silva GF, Geyvandova N, Stanciu C, Rabbia M, McKenna M, Thommes JA, Harrison SA; PROGRESS Study Investigators. Induction pegylated interferon alfa-2a and high dose ribavirin do not increase SVR in heavy patients with HCV genotype 1 and high viral loads. Gastroenterology. 2010 Dec;139(6):1972-83. Epub 2010 Sep 30.

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00394277 History of Changes
Other Study ID Numbers:	NV18210
Study First Received:	October 30, 2006
Results First Received:	May 27, 2010
Last Updated:	July 30, 2010
Health Authority:	United States: Food and Drug Administration

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