Recruitment

Recruitment Status
Completed

Inclusion Criterias

Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.
Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.
Compensated liver disease (Child-Pugh Class A).
...
Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.
Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.
Compensated liver disease (Child-Pugh Class A).
Previous participation in a donor protocol in which treatment or re-treatment with Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion.
Chronic hepatitis C.
For females of childbearing potential, a negative pregnancy test within 24 hours prior to first dose of study drug.
Have not received any other anti-hepatitis C virus treatment after the completion of the donor protocol.
Adult patients, ≥ 18 years of age.

Exclusion Criterias

Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.
Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).
Patients with hemoglobinopathies.
...
Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.
Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).
Patients with hemoglobinopathies.
Pregnant or breastfeeding women.
Male partners of women who are pregnant.
Liver disease other than chronic hepatitis C, including hepatic carcinoma.

Summary

Conditions
Hepatitis C, Chronic
Type
Interventional
Phase
Phase 3
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.
Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.
Compensated liver disease (Child-Pugh Class A).
...
Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.
Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.
Compensated liver disease (Child-Pugh Class A).
Previous participation in a donor protocol in which treatment or re-treatment with Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion.
Chronic hepatitis C.
For females of childbearing potential, a negative pregnancy test within 24 hours prior to first dose of study drug.
Have not received any other anti-hepatitis C virus treatment after the completion of the donor protocol.
Adult patients, ≥ 18 years of age.

Exclusion Criterias

Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.
Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).
Patients with hemoglobinopathies.
...
Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.
Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).
Patients with hemoglobinopathies.
Pregnant or breastfeeding women.
Male partners of women who are pregnant.
Liver disease other than chronic hepatitis C, including hepatic carcinoma.

Locations

Sao Paulo, 1323020
Manhasset, New York, 11030
Newark, New Jersey, 07102
Baltimore, Maryland, 21205
Sao Paulo, 01246-000
...
Sao Paulo, 1323020
Manhasset, New York, 11030
Newark, New Jersey, 07102
Baltimore, Maryland, 21205
Sao Paulo, 01246-000
Napoli, 80131
Wellington, Florida, 33414
Bellevue, Washington, 98004
Orlando, Florida, 32809
Boise, Idaho, 83702
Dallas, Texas, 75203
Marietta, Georgia, 30060
Santurce, 00909
San Juan, 00921-3200
Gainesville, Florida, 32610
Vineland, New Jersey, 08360
Bergamo, 24128
Barcelona, 08803
Seattle, Washington, 98133
Sarasota, Florida, 34243
Jacksonville, Florida, 32209
Ribeirao Preto, 14049-900
Framingham, Massachusetts, 01702
Houston, Texas, 77030
Kansas City, Kansas, 66160
San Diego, California, 92154
Gainesville, Florida, 32610-0214
Orlando, Florida, 32803
Statesville, North Carolina, 28677
Tacoma, Washington, 98403
Charlottesville, Virginia, 22906-0013
San Antonio, Texas, 78215
Ponce, 00716
Adelaide, 5000
San Francisco, California, 94115
Atlanta, Georgia, 30309
Portland, Oregon, 97201
Birmingham, Alabama, 35295-0005
Vandoeuvre-les-nancy, 54511
Aurora, Colorado, 80045
Miami, Florida, 33136-1051
Plymouth, Minnesota, 55446
Herston, 4006
Philadelphia, Pennsylvania, 19104
Long Beach, California, 90822
Binghamton, New York, 13903
La Jolla, California, 92037-1030
Plymouth, PL6 8DH
Cleveland, Ohio, 44106
Iowa City, Iowa, 52242
Providence, Rhode Island, 02905
Poughkeepsie, New York, 12601
Atlanta, Georgia, 30308
San Diego, California, 92123
Germantown, Tennessee, 38138
Taoyuan, 333
Thessaloniki, 56429
New York, New York, 10016
Worcester, Massachusetts, 01655
San Juan, 00936-5067
New York, New York, 10021
Indianapolis, Indiana, 46202
Warszawa, 01-201
Salvador, 40150-130
Honolulu, Hawaii, 96817
Durham, North Carolina, 27710
Lancaster, Pennsylvania, 17604-3200

Tracking Information

NCT #
NCT01853254
Collaborators
Not Provided
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche