Efficacy and Safety of PEG-Intron plus Rebetol in Subjects with Chronic Hepatitis C Genotype 1 Non Responder to Pegasys - Non-Responder Study

• Register: EUCTR
• Last refreshed on: 15 April 2013
• Main ID: EUCTR2004-001220-20-AT
• Date of registration: 21/12/2004
• Prospective Registration: Yes
• Primary sponsor: Integrated Therapeutics Group, Incorporated - a subsidiary of Schering-Plough
• Public title: Efficacy and Safety of PEG-Intron plus Rebetol in Subjects with Chronic Hepatitis C Genotype 1 Non Responder to Pegasys - Non-Responder Study
• Scientific title: Efficacy and Safety of PEG-Intron plus Rebetol in Subjects with Chronic Hepatitis C Genotype 1 Non Responder to Pegasys - Non-Responder Study
• Date of first enrolment: 25/01/2005
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001220-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Austria, Germany, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
- 18-70 years of age
- Chronic Hepatitis C patients, non-responders to Pegasys/ribavirin treatment
- no other interferon treatment except Pegasys
- no other hepatitis C treatment
- TSH within normal limits
- Compensated liver disease with the following minimum hematologic and biochemical criteria at the Day 1 visit within normal limits:
• Hemoglobin values of equal to or more than12 gm/dL for females and 13 gm/dL for males.
• WBC equal to or more than 3,000/mm3
• Neutrophil count equal to or more than 1,500/mm3
• Platelet count equal to or more than 80,000/mm3
• Direct bilirubin within normal limits
• Indirect bilirubin within normal limits (unless non-hepatitis related factors such as Gilbert's disease explain an indirect bilirubin rise). In such cases indirect bilirubin should be less than or equal to 3.0 mg/dL (less than or equal to 51.3 µmol/L)
• Albumin within normal limits
• Serum creatinine within normal limits
• Subject must be a non-responder, defined as having received and not having responded to a prior treatment consisting of one course of Pegasys 180 mcg QW in combination with ribavirin 1000-1200 mg daily for a minimum of 12 weeks and:
(a) Subject must be found to be HCV-RNA positive with less than a 2 log drop at 12 weeks of treatment
or
(b) is PCR positive at End Of Treatment whether End Of Treatment happened at week 48 or earlier


Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Pregnant females
- subjects over 125kg
- Previously untreated subjects
- Subject discontinued from Pegasys due to adverse event
- Subject is co-infected with HIV and/or HBV
- Suspected hypersensitivity to interferon alpha or pegintron or ribavirin
- Subject has had organ transplants
- History of hepatocellular carcinoma, known coagulation disorders, G6PD deficiency, moderate to severe depression, craniocerebral trauma or active seizure disorders, cardiovascular dysfunction, chronic lung disease, immune-mediated disease, clinical gout, creatinine clearance less than 50 ml/min
- Subject needs use of chronic systemic steroids
- subject is active drug abuser.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic Hepatitis C, Genotype 1

Intervention(s)

Trade Name: PegIntron
Product Name: Pegintron
Pharmaceutical Form: Injection*
Other descriptive name: PegIntron vials
Concentration unit: µg/ml microgram(s)/millilitre
Concentration number: 50-150
Other descriptive name: PegIntron Redipen
Concentration unit: µg/ml microgram(s)/millilitre
Concentration number: 80-150

Trade Name: Rebetol
Product Name: Rebetol 200mg
Pharmaceutical Form: Capsule, hard
Concentration unit: mg milligram(s)
Concentration number: 200-

Primary Outcome(s)

Primary end point(s): Proportion of subjects who have achieved sustained virological response at 24 weeks post end of treatment

Secondary Objective: Duration of response and safety.

Main Objective: To demonstrate that non-responders to Pegasys/ribavirin may respond to a weight-based Pegintron/Rebetol treatment.

Secondary ID(s)

P03833