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An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant

Information source: Janssen Scientific Affairs, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitits C

Intervention: Simeprevir (Drug); Sofosbuvir (Drug); Ribavirin (Drug); Simeprevir (Drug); Sofosbuvir (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Janssen Scientific Affairs, LLC

Official(s) and/or principal investigator(s):
Janssen Scientific Affairs, LLC Clinical Trial, Study Director, Affiliation: Janssen Scientific Affairs, LLC

Summary

The purpose of this study is to evaluate sustained virologic response 12 weeks after the end of treatment (SVR12) following 12 weeks of simeprevir plus sofosbuvir with and without ribavirin (RBV) and 24 weeks of simeprevir plus sofosbuvir without RBV in post orthotopic liver transplant participants with recurrent hepatitis (inflammation of the liver) C virus (HCV) Genotype 1 infection.

Clinical Details

Official title: A Phase 2 Open-Label Study in Patients With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant to Explore the Safety And Efficacy of Simeprevir and Sofosbuvir With and Without Ribavirin

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With Sustained Virologic Response After 12 Weeks of end of Treatment (SVR12)

Secondary outcome:

Percentage of Participants With Sustained Virologic Response After 4 Weeks of end of Treatment (SVR4)

Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)

Percentage of Participants With Viral Breakthrough

Percentage of Participants With Viral Relapse

Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Score at Week 24 (for Arms 1 and 2) and Week 36 (for Arm 3)

Change From Baseline in EuroQol 5 - Dimension (EQ-5D) Questionnaire Score at Weeks 4, 8, 12, 16, 20, 24 (for all treatment arms) and Week 36 (for Arm 3)

Detailed description: This is a Phase 2, multicenter (when more than one hospital or medical school team work on a medical research study), partially randomized (study drug is assigned by chance), and open-label (all people know the identity of the intervention) study to explore the safety and efficacy of simeprevir plus sofosbuvir. The study will consist of a screening period (Screening and Baseline), followed by randomization. First 33 non-cirrhotic participants will be randomly assigned in a ratio of 1: 1:1 into 1 of 3 treatment arms, and up to 12 cirrhotic participants will be enrolled and all will be assigned to Arm 3. All participants in treatment Arms 1 and 2 will return for treatment visits at Weeks 1, 2, 4, 8, 12, and post-treatment follow-up visits on Weeks 16 and 24. All participants in treatment Arm 3 will return for treatment visits at Weeks 1, 2, 4, 8, 12, 16, 20, and 24, and post-treatment follow-up visits on Weeks 28 and 36. Participants will receive simeprevir plus sofosbuvir and RBV for a 12-week treatment period in Arm 1, simeprevir plus sofosbuvir without RBV for a 12-week treatment period in Arm 2 and simeprevir plus sofosbuvir for a 24-week treatment period in Arm 3. Efficacy will primarily be evaluated by SVR12. Participants' safety will be monitored throughout the study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participant must be infected with Hepatitis C virus (HCV) Genotype 1 (1a or 1b) with

Baseline HCV ribonucleic acid (RNA) greater than (>) 10,000 international unit per milliliter (IU/mL). Retesting of HCV RNA to assess eligibility will be allowed once, using an unscheduled visit during the Screening period

- Participant must have had an orthotopic liver transplant greater than or equal to

(>=) 6 months to 15 years prior to enrollment

- Participant must have had primary liver transplant

- Participant must be on a stable immunosuppressive regimen for at least 3 months prior

to the Screening visit. Immunosuppression regimens may include calcineurin inhibitors (for example, tacrolimus), mammalian target of rapamycin (mTOR) inhibitor, mycophenolate mofetil, prednisone, prednisolone less than or equal to (<=) 5 milligram per day (mg/day), other corticosteroids (except systemic dexamethasone), sirolimus, everolimus, or azathioprine. Stable immunosuppression includes normal adjustment of immunosuppressant dose but excludes changes in immunosuppressant medication and/or treatment of rejection.

- Participant's renal function as measured by the Cockcroft Gault formula must be >30

milliliter per minute (mL/min) Exclusion Criteria:

- Participants received prior treatment with an investigational or Food and Drug

Administration (FDA) approved direct-acting antiviral drug for the treatment of hepatitis C. Prior HCV treatment with interferon or peginterferon with or without ribavirin (RBV) is allowed but must have been completed at least 3 months prior to Screening

- Participants with hepatic decompensation defined by any of the following: 1) Any

post-liver transplant clinical signs including ascites, hepatic encephalopathy, and/or evidence of varices with or without variceal bleeding, and 2) Child-Turcotte-Pugh (CTP) score >=7

- Participant has (post-transplant) any underlying serious or life-threatening

condition, such as severe uncontrolled cardiopulmonary disease, vascular disease, rheumatologic condition, renal failure, dialysis, ongoing systemic infection, uncontrolled malignancy, or other serious illness that would compromise adherence to medications and ability to comply with all aspects of the study protocol

- Any other active, clinically significant disease or clinically significant findings

during the Screening period of medical history, physical examination, laboratory testing, or electrocardiogram (ECG) recording that, in the investigator's opinion, would compromise the participant's safety or could interfere with the participant participating in and completing the study. Retesting of laboratory results that lead to exclusion will be allowed once using an unscheduled visit during the Screening period to assess eligibility

- Participant is a woman who is pregnant, breast-feeding, or planning to become

pregnant while enrolled in this study or within 6 months after the last dose of ribavirin (or longer when dictated by local regulations)

Locations and Contacts

Aurora, Colorado, United States

Gainesville, Florida, United States

Miami, Florida, United States

Boston, Massachusetts, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

New York, New York, United States

Durham, North Carolina, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Dallas, Texas, United States

Additional Information

Starting date: August 2014
Last updated: July 29, 2015

Page last updated: August 23, 2015

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