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ISRCTN
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ISRCTN45169013
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ClinicalTrials.gov identifier
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Public title
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Comparison of Three Regimens of PEG-Intron plus Ribavirin in the Treatment of Chronic Hepatitis C, Genotype 2 or 3, in Previously Untreated Patients
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Scientific title
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Acronym
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Redd 2-3 Study (Reduction of dose and duration)
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Serial number at source
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3272
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Study hypothesis
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Non-Inferiority of lower dosage with 1.0 µg/kg PEG-Intron in comparison to the standard treatment with 1.5 µg/kg PEG-Intron and non-inferiority of shorter treatment duration of 16 weeks in comparison to the standard treatment with a duration of 24 weeks.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Chronic hepatitis C of genotype 2 or 3
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Participants - inclusion criteria
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Haemoglobin >12 g/kl (females); >13 g/kl (males); Platelet count >100,000/mm^3; Neutrophil count >1500/mm^3; Adult male or female chronic hepatitis C (CHC) patients (HCV-RNA-positive in serum) with compensated liver disease (Child-Pugh Score <7) and indication for treatment according on current consensus guidelines (1. NIH Consensus Conference on the Management of Hepatitis C, 2002; 2. German Consensus Conference on Hepatitis B and C, Z Gastro 2004); >18 to <70 years of age; at least one abnormal ALT value in the last year; HCV genotype 2 or 3; not previously treated with any interferon or ribavirin alone or in combination; TSH level within normal limits; Women of childbearing potential: negative pregnancy test performed at baseline; Sexually active female subjects of childbearing potential: adequate contraception or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for seven months after stopping treatment; Sexually active male subjects: acceptable methods of contraception(vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for seven months after stopping treatment; written informed consent.
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Participants - exclusion criteria
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Patients younger than 18 years; Patients older than 70 years of age; Anti-human immunodeficiency virus (HIV) positivity; HBsAg-positivity; existence of, or a history of severe psychiatric condition, particularly severe depression, suicidal ideation of suicide attempt; Autoimmune hepatitis; or history of autoimmune disease; patients with severe renal dysfunction or creatinine clearance <50 ml/min; active drug abuse.
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Anticipated start date
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01/05/2003
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Anticipated end date
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31/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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670
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Interventions
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Application of:
a. 1.5 µg/kg Peg-Interferon alpha-2b subcutaneously (sc) + 800-1200 mg ribavirin orally (po) weight adapted for 24 weeks
b. 1.0 µg/kg Peg-Interferon alpha-2b sc + 800-1200 mg ribavirin po weight adapted for 24 weeks
c. 1.5 µg/kg Peg-Interferon alpha-2b sc + 800-1200 mg ribavirin po weight adapted for 16 weeks
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Primary outcome measure(s)
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Sustained HCV-virological response (HCV-RNA negative in serum by a standard HCV-PCR with a detection limit of at least 600 IU/ml) 24 weeks after the end of treatment.
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Secondary outcome measure(s)
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Virological response rates (HCV-RNA negative in serum by a standard HCV-PCR with a detection limit of at least 600 IU/ml) at the end of therapy; biochemical responses as determined by ALT and AST levels at the end of treatment and at the end of follow up; severity and frequency of adverse events; quality of life (assessed by SF-36).
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Sources of funding
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Medical University Hannover (Medizinische Hochschule Hannover)
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Trial website
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http://www.kompetenznetz-hepatitis.de/en/study_house/redd_en.htm
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Publications
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Contact name
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Prof
Michael P.
Manns
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Address
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Medizinische Hochschule Hannover
Director of the Department for Gastroenterology, Hepatology, and Endocrinology
Carl-Neuberg-Str. 1
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City/town
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Hannover
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Zip/Postcode
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30625
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Country
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Germany
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Tel
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+49 (0)5115323305
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Fax
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+49 (0)5115324896
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Email
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manns.michael@mh-hannover.de
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Sponsor
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Medical University Hannover (Medizinische Hochschule Hannover), Kompetenznetz Hepatitis (Germany)
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Address
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Department for Gastroenterology, Hepatology, and Endocrinology
Carl-Neuberg-Str. 1
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City/town
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Hannover
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Zip/Postcode
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30625
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Country
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Germany
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Tel
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+49 (0)5115326815
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Fax
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+49 (0)5115326820
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Email
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hep-net@mh-hannover.de
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Sponsor website:
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http://www.kompetenznetz-hepatitis.de
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Date applied
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02/09/2005
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Last edited
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25/08/2006
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Date ISRCTN assigned
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26/09/2005
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