Trial Outcomes & Findings for Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients (NCT NCT01592006)

NCT ID: NCT01592006

Last Updated: 2016-06-15

Results Overview

To evaluate the efficacy of triple antiviral therapy, consisting of pegylated interferon alfa-2a (Pegasys®), ribavirin, and telaprevir therapy in liver transplant recipients with hepatitis C. This will be measured and reported by sustained virologic response (defined as undetectable HCV RNA in the blood 24 weeks after completing therapy \[SVR24\])

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

3 years from start of study

Results posted on

2016-06-15

Participant Flow

Since new better drug options had became available, the intervention drug of this study was no longer the best option for the patients. Thus this study was terminated.

Participant milestones

Participant milestones
Measure	HCV, LT, Pegasys, Ribavirin, Telaprevir Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HCV, LT, Pegasys, Ribavirin, Telaprevir n=3 Participants Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
Age, Continuous	56 years STANDARD_DEVIATION 4.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years from start of study

Outcome measures

Outcome measures
Measure	HCV, LT, Pegasys, Ribavirin, Telaprevir n=3 Participants Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
The Efficacy of Triple Antiviral Therapy	100 percentage of participants

SECONDARY outcome

Timeframe: 6 years from the start of the study

Tolerability and Safety will be measured and reported by serious adverse events.

Outcome measures

Outcome measures
Measure	HCV, LT, Pegasys, Ribavirin, Telaprevir n=3 Participants Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
Safety of Triple Antiviral Therapy in HCV Infected OLT Recipients	0 participants

Adverse Events

HCV, LT, Pegasys, Ribavirin, Telaprevir

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HCV, LT, Pegasys, Ribavirin, Telaprevir n=3 participants at risk Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
Gastrointestinal disorders Anorectal discomfort	66.7% 2/3 • 1 year
Skin and subcutaneous tissue disorders Rash	66.7% 2/3 • 1 year
General disorders Fatigue	100.0% 3/3 • 1 year
Psychiatric disorders Irritable	66.7% 2/3 • 1 year
General disorders MVA	33.3% 1/3 • 1 year
Blood and lymphatic system disorders Anemia	66.7% 2/3 • 1 year
Nervous system disorders Headache	66.7% 2/3 • 1 year
General disorders Mouth sores	33.3% 1/3 • 1 year
Gastrointestinal disorders Nausea	33.3% 1/3 • 1 year
General disorders Fever	33.3% 1/3 • 1 year
Gastrointestinal disorders Diarrhea	33.3% 1/3 • 1 year
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • 1 year

Additional Information

Dr. Helen S. Te

University of Chicago Medical Center

Phone: 773-702-2395

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place