Hepatitis C, Chronic
Conditions
Brief summary
This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS monotherapy, at a maximum dose of 180 µg weekly, or combination therapy with Copegus, 800-1200 mg daily, as continuation of treatment after the wash-out period defined in their donor protocol. PEGASYS treatment is not to exceed the approved treatment duration of 48 weeks in genotype G1 with a treatment-free follow up period of 24 weeks.
Interventions
Pegylated-interferon alfa-2a was administered subcutaneously once weekly.
DRUGRibavirin
Participants received ribavirin with food, as the bioavailability of ribavirin is increased when taken with food. Ribavirin was administered as split doses, that is, 2 doses were given 12 hours apart, 1 in the morning and 1 in the evening. Participants received either 1000 or 1200 mg ribavirin per day according to body weight: 400 mg (2 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing \< 75 kg or 600 mg (3 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing ≥ 75 kg.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, ≥ 18 years of age. * Chronic hepatitis C (CHC) patients with compensated liver disease (Child-Pugh A) who have participated in a donor protocol where access to treatment or re-treatment with PEGASYS monotherapy or in combination with Copegus was promised or deemed appropriate after completion of the donor protocol.
Exclusion criteria
* Evidence of decompensated liver disease (Child B or C cirrhosis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced at Least 1 Adverse Event. | Baseline through 24 weeks after the end of treatment (up to 72 weeks) | An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
Countries
Austria, Canada, France, Germany, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pegylated-interferon Alfa-2a Plus Ribavirin Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing \< 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative/Other | 2 |
| Overall Study | Insufficient Therapeutic Response | 2 |
| Overall Study | Violation of Selection Criteria at Entry | 7 |
| Overall Study | Withdrew Consent | 3 |
Baseline characteristics
| Characteristic | Pegylated-interferon Alfa-2a Plus Ribavirin |
|---|---|
| Age Continuous | 48.5 years STANDARD_DEVIATION 9.35 |
| Body Mass Index (BMI) | 26.5 kg/m^2 STANDARD_DEVIATION 4.53 |
| Height | 170.0 cm STANDARD_DEVIATION 7.28 |
| Race/Ethnicity, Customized Black | 2 participants |
| Race/Ethnicity, Customized Caucasian | 28 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 12 Participants |
| Weight | 76.97 kg STANDARD_DEVIATION 16.146 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 30 |
| serious Total, serious adverse events | 4 / 30 |
Outcome results
Primary
Percentage of Participants Who Experienced at Least 1 Adverse Event.
An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Baseline through 24 weeks after the end of treatment (up to 72 weeks)
Population: All enrolled patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pegylated-interferon Alfa-2a Plus Ribavirin | Percentage of Participants Who Experienced at Least 1 Adverse Event. | 80.0 Percentage of participants |