Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected With HCV Genotype 2 or 3

This study has been completed.

Study NCT00056862 Information provided by National Institutes of Health Clinical Center (CC)

First Received on March 25, 2003. Last Updated on May 26, 2011 History of Changes

Results First Received: November 12, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hepatitis C
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
Between Dec 2003 and Dec 2004, 31 patients were enrolled into the low-dose group and were treated with peginterferon alfa-2a 90ug/week and ribavirin 400 mg/twice daily for 24 week. From Feb 2005, all subsequent patients were enrolled into a standard-dose group and treated for 24 weeks with the doses of the approved regimen.

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
Low Dose Group	All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
Standard Dose Group	All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.

Participant Flow: Overall Study

	Low Dose Group	Standard Dose Group
STARTED	31	27
COMPLETED	30	27
NOT COMPLETED	1	0
Protocol Violation	1	0

Baseline Characteristics

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Reporting Groups

	Description
Low Dose Group	All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
Standard Dose Group	All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.

Baseline Measures

	Low Dose Group	Standard Dose Group	Total
Number of Participants [units: participants]	30	27	57
Age [units: years] Mean ( Full Range )	48 ( 29 to 62 )	47 ( 26 to 69 )	48 ( 26 to 69 )
Gender [units: participants]
Female	15	14	29
Male	15	13	28
Race/Ethnicity, Customized [units: participants]
Caucasian	26	20	46
Asian	2	5	7
Hispanic	1	0	1
African-American	1	2	3
Region of Enrollment [units: participants]
United States	30	27	57
ALT [units: U/L] Mean ± Standard Deviation	91 ± 69	97 ± 85	94 ± 77
HCV RNA [units: log IU/mL] Mean ± Standard Deviation	6.3 ± 0.82	5.9 ± 1.02	6.1 ± 0.92
Genotype [units: participants]
HCV Genotype 2	21	13	34
HCV Genotype 3	9	14	23

Outcome Measures

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1. Primary:

Virological Response (Intention to Treat) [ Time Frame: 6 months after stopping therapy ]

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2. Primary:

Virological Response Category (Per Protocol) [ Time Frame: 6 months after therapy ]

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3. Secondary:

First Phase Decline in Logarithm of HCV RNA Level [ Time Frame: 2 days ]

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4. Secondary:

Slope of Second Phase Decline in HCV Levels [ Time Frame: day 7 to day 28 ]

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5. Secondary:

Time to Negativity [ Time Frame: 24 weeks ]

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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:

All Principal Investigators ARE employed by the organization sponsoring the study.

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: Jay H. Hoofnagle, M.D.
Organization: National Institute of Diabetes and Digestive and Kidney Diseases
phone: 3014961333
e-mail: hoofnaglej@extra.niddk.nih.gov

Publications of Results:

Rotman Y, Borg BB, Soza A, Feld JJ, Modi AA, Loomba R, Lutchman G, Rivera E, Doo E, Ghany MG, Heller T, Neumann AU, Liang TJ, Hoofnagle JH. Low- and standard-dose peginterferon alfa-2a for chronic hepatitis C, genotype 2 or 3: efficacy, tolerability, viral kinetics and cytokine response. Aliment Pharmacol Ther. 2010 May;31(9):1018-27. Epub 2010 Jan 16.

Other Publications:

Liang TJ, Rehermann B, Seeff LB, Hoofnagle JH. Pathogenesis, natural history, treatment, and prevention of hepatitis C. Ann Intern Med. 2000 Feb 15;132(4):296-305. Review.

Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. Review. No abstract available.

Neumann AU, Lam NP, Dahari H, Gretch DR, Wiley TE, Layden TJ, Perelson AS. Hepatitis C viral dynamics in vivo and the antiviral efficacy of interferon-alpha therapy. Science. 1998 Oct 2;282(5386):103-7.

Responsible Party:	Jay H. Hoofnagle, M.D./National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health
ClinicalTrials.gov Identifier:	NCT00056862 History of Changes
Other Study ID Numbers:	030136, 03-DK-0136
Study First Received:	March 25, 2003
Results First Received:	November 12, 2010
Last Updated:	May 26, 2011
Health Authority:	United States: Food and Drug Administration