| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Chronic Hepatitis C, Genotype 2 or 3 |
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| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To examine the effect of peg-Intron dose by comparing the "standard" regimen, peg-Intron 1.5 mcg/kg qW sc plus ribavirin 800-1200 mg daily, to a lower dose regimen, peg-Intron 1.0 mcg/kg qW sc plus ribavirin 800-1200 mg daily, using a 24 week treatment duration for both arms, to examine the effect of duration of treatment by comparing the "standard" regimen, peg-Intron 1.5 mcg/kg qW sc plus ribavirin 800-1200 mg daily, using a 24 week treatment duration to the same regimen using a shorter treatment duration of 16 weeks. |
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| E.2.2 | Secondary objectives of the trial |
| To examine the efficacy of PEG-Intron 1.5 mcg/kg qW sc plus ribavirin 800-1200 mg and adherence to therapy in a global phase IIIb study. |
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
The subject must meet ALL of the criteria listed below for entry into the study:
1) Haemoglobin > or = 11 g/dL (females); > or =12 g/dL (males)
2) Platelet count > or = 100,000/mm3
3) Neutrophil count > or = 1,500/mm3
4) 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, published in Z Gastro 2004; 42 (8): 677-730).
5) > or =18 to < or = 70 years of age
6) At least one abnormal ALT value in the last year
7) HCV genotype 2 or 3
8) Not previously treated with any interferon or ribavirin alone or in combination
9) TSH level must be within normal limits
10) At the Screen Visit, glucose must be 70-140 mg/dL. Results between 116-140 mg/dL require repeat fasting glucose to be less than140 mg/dL and HbA1C less than or equal to 8.5%. HbA1C must be less than or equal to 8.5% in diabetic subjects (whether on medication or diet controlled).
11) Female subjects cannot be pregnant or breastfeeding and must be either postmenopausal, surgically sterile or using 2 methods of birth control. While abstinence from sexual activity is the only certain method to prevent pregnancy, female patients of childbearing potential who are or who anticipate the possibility of becoming sexually active with a male partner must use a combination of the following 2 methods :
1) contraceptive pill or IUD or depot hormonal preparation (ring, injection implant) and
2) A barrier method of contraception such as diaphragm, sponge with spermicide, condom, or a method of birth control considered acceptable by the study physician.
Contraceptive measures will be reviewed with female subjects at each visit. Dual methods of contraception must be used for 6 months after treatment discontinuation.
12) Sexually active male subjects must be practicing acceptable methods of contraception (vasectomy, use of condom plus spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment
13) Subjects must be willing to give written informed consent and able to adhere to dosing and visit schedules.
14) Confirmation by the principal investigator or a sub-investigator that sexually active females of childbearing potential are practicing adequate contraception.
15) A serum pregnancy test obtained at Screen Visit prior to the initiation of treatment must be negative
16) Confirmation by the principal investigator or a sub-investigator that sexually active male subjects are practicing a method of contraception considered acceptable (vasectomy, condom plus spermicide, plus relationship with a female partner who practices an acceptable method of contraception). Contraception must be used during the treatment period and for seven months (or 6 months, according to local label) after the completion of therapy, including condom use by male subjects with pregnant partners.
17) For subjects with a history of hypertension or diabetes, written clearance from an ophthalmologist has to be obtained prior to treatment start.
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| E.4 | Principal exclusion criteria |
The subject will be excluded from entry into the study if ANY of the criteria listed below are met.
1) Patients younger than 18 years
2) Patients older than 70 years of age.
3) Known positive anti-HIV antibodies
4) Known positive HBsAg antibodies
5) Patients with severe renal dysfunction or creatinine clearance < 50 mL/min must not be treated with PEG-Intron -Rebetol
6) Pregnant women, women who plan to become pregnant, male subjects whose partner wants to become pregnant, and breastfeeding women.
7) Suspected hypersensitivity to any interferon or ribavirin product.
8) Subject has used any investigational product within 30 days prior to enrollment
9) Subject is participating in any other clinical study
10) Any cause of liver disease other than chronic hepatitis C, including but not limited to:
a) Hemochromatosis
b) Alpha-1 antitrypsin deficiency
c) Wilson's disease
d) Autoimmune hepatitis
e) Alcoholic liver disease
f) Drug-related liver disease
11) Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma)
12) Known coagulation diseases such as hemophilia; hemoglobin diseases (e.g. thalassemia)
13) Known G6PD deficiency
14) Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, or hepatic encephalopathy.
15) Subjects with organ transplants, except for corneal or hair transplant.
16) Any known preexisting medical condition that could interfere with the subject's participation in and completion of study, such as:
a. Preexisting psychiatric condition, especially moderate to severe depression, or a history of severe psychiatric disorder, such as psychosis, suicidal ideation, or suicide attempts. Severe depression includes the following:
i. hospitalization for depression
ii. electroconvulsive therapy for depression, or
iii. depression causing a prolonged absence from work or significantly altering daily functions.
Subjects with mild depression may be considered for entry into the study provided that a pre-treatment assessment demonstrates that the subject's emotional status is clinically stable, in which case a management plan must be formulated for the subject; this management plan will become a part of the subject's medical record.
b. Craniocerebral trauma which is not a concussion or active seizure disorders requiring medication.
c. Clinically significant ECG abnormalities and/or cardiovascular dysfunction within 6 previous months (e.g., angina, congestive heart failure, recent myocardial infarction, or significant arrhythmia).
d. Chronic lung disease (e.g., chronic obstructive lung disease)
e. Poorly controlled diabetes mellitus
f. Immune-mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis)
g. Clinical gout
17) Subject is or was a substance abuser, such as alcohol (80 gm/day or more), methadone, IV, oral or inhaled drugs. To be considered for inclusion into the protocol, the subject must have abstained and agree to abstain from using any of the above for at least 6 months. Subjects treated with buprenorphine (Subutex) who have been stable for 6 months may be included
18) Any other condition that, in the investigator’s opinion, could determine that subject's participation in the study is not indicated or could interfere with the subject's participation in and completion of study.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary endpoint for the study is 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.
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| End of trial : when last subject has completed 24-week follow-up. |
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
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