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
NCT00302081
Protocol/serial number
3272
Study information
Scientific title
Comparison of Three Regimens of PEG-Intron plus Ribavirin in the Treatment of Chronic Hepatitis C, Genotype 2 or 3, in Previously Untreated Patients
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 measure
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 (if study stopped)
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
Total final enrolment
682
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)
Sponsor details
Department for Gastroenterology
Hepatology
and Endocrinology
Carl-Neuberg-Str. 1
Hannover
30625
Germany
+49 (0)5115326815
hep-net@mh-hannover.de
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Medical University Hannover (Medizinische Hochschule Hannover)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in https://pubmed.ncbi.nlm.nih.gov/21237227/ (added 12/01/2021)