ISRCTN - ISRCTN45169013: Comparison of Three Regimens of PEG-Intron plus Ribavirin in the Treatment of Chronic Hepatitis C, Genotype 2 or 3, in Previously Untreated Patients

Plain English Summary

Not provided at time of registration

Trial website

http://www.kompetenznetz-hepatitis.de/en/study_house/redd_en.htm

Contact information

Type

Scientific

Primary contact

Prof Michael P. Manns

ORCID ID

Contact details

Medizinische Hochschule Hannover
Director of the Department for Gastroenterology
Hepatology
and Endocrinology
Carl-Neuberg-Str. 1
Hannover
30625
Germany
+49 (0)5115323305
manns.michael@mh-hannover.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3272

Study information

Scientific title

Acronym

Redd 2-3 Study (Reduction of dose and duration)

Study hypothesis

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic hepatitis C of genotype 2 or 3

Intervention

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

Intervention type

Drug

Phase

Not Specified

Drug names

PEG-Intron and Ribavirin

Primary outcome measures

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.

Secondary outcome measures

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).

Overall trial start date

01/05/2003

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

670

Participant exclusion criteria

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.

Recruitment start date

01/05/2003

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Germany

Trial participating centre

Medizinische Hochschule Hannover
Hannover
30625
Germany

Sponsor information

Organisation

Medical University Hannover (Medizinische Hochschule Hannover), Kompetenznetz Hepatitis (Germany)