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

ISRCTN ISRCTN45169013
DOI https://doi.org/10.1186/ISRCTN45169013
ClinicalTrials.gov number NCT00302081
Secondary identifying numbers 3272
Submission date
02/09/2005
Registration date
26/09/2005
Last edited
12/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Michael P. Manns
Scientific

Medizinische Hochschule Hannover
Director of the Department for Gastroenterology, Hepatology, and Endocrinology
Carl-Neuberg-Str. 1
Hannover
30625
Germany

Phone +49 (0)5115323305
Email manns.michael@mh-hannover.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleComparison of Three Regimens of PEG-Intron plus Ribavirin in the Treatment of Chronic Hepatitis C, Genotype 2 or 3, in Previously Untreated Patients
Study acronymRedd 2-3 Study (Reduction of dose and duration)
Study objectivesNon-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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedChronic hepatitis C of genotype 2 or 3
InterventionApplication 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)PEG-Intron and Ribavirin
Primary outcome measureSustained 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 measuresVirological 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 study start date01/05/2003
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants670
Total final enrolment682
Key inclusion criteriaHaemoglobin >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.
Key exclusion criteriaPatients 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.
Date of first enrolment01/05/2003
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Germany

Study participating centre

Medizinische Hochschule Hannover
Hannover
30625
Germany

Sponsor information

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

Department for Gastroenterology, Hepatology, and Endocrinology
Carl-Neuberg-Str. 1
Hannover
30625
Germany

Phone +49 (0)5115326815
Email hep-net@mh-hannover.de
Website http://www.kompetenznetz-hepatitis.de
ROR logo "ROR" https://ror.org/00f2yqf98

Funders

Funder type

University/education

Medical University Hannover (Medizinische Hochschule Hannover)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2011 12/01/2021 Yes No

Editorial Notes

12/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NCT code has been added.