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 (NCT) | NCT00302081 |
| Protocol serial number | 3272 |
| Sponsor | Medical University Hannover (Medizinische Hochschule Hannover), Kompetenznetz Hepatitis (Germany) |
| Funder | Medical University Hannover (Medizinische Hochschule Hannover) |
- 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
Contact information
Prof Michael P. Manns
Scientific
Scientific
Medizinische Hochschule Hannover
Director of the Department for Gastroenterology, Hepatology, and Endocrinology
Carl-Neuberg-Str. 1
Hannover
30625
Germany
| Phone | +49 (0)5115323305 |
|---|---|
| manns.michael@mh-hannover.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study acronym | Redd 2-3 Study (Reduction of dose and duration) |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | PEG-Intron and Ribavirin |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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). |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 670 |
| Total final enrolment | 682 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Medizinische Hochschule Hannover
Hannover
30625
Germany
30625
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
