Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C

Phase 4

Completed

• Conditions: Liver Transplantation; Hepatitis C
• Interventions: Drug: cyclosporin (Neoral); Drug: tacrolimus (Prograf)

• Registration Number: NCT00938860
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will assess the rates of Sustained Virological Response following anti-viral therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with recurrent Hepatitis C and treated with Neoral or tacrolimus.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-07-13
• Study First Posted: 2009-07-14
• Study Start: 2009-09
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-04-25
• Results First Submitted QC: 2014-04-25
• Results First Posted: 2014-05-26
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoral	cyclosporin (Neoral)	Neoral capsules bid, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
tacrolimus	tacrolimus (Prograf)	Tacrolimus capsules bid, doses were adjusted as necessary to achieve and maintain recommended C0 target ranges.

Primary Outcome Measures

Name	Time	Method
Number of Participants Sustained Virological Response (SVR) Following Treatment of Hepatitis C Virus (HCV) Infection With Peg-IFN and Ribavirin in Liver Transplanted Recipients on Maintenance Therapy With Neoral or Tacrolimus	Week 24	The achievement of SVR, defined as HCV RNA below limit of detection at the end of AV treatment, 24 weeks after end of AV treatment (W24 post). A dichotomous variable (SVR achieved: Yes/No) was computed. A patient was classified as non-responder (SVR not achieved) if HCV RNA was detectable at the completion of antiviral treatment, at W24post, or at any time between W24 and completion of antiviral treatment. The HCV RNA detection limit was \<15 IU/ml (\<1.18 log IU/ml)

Secondary Outcome Measures

Name	Time	Method
Number of Events of the Composite Endpoint of Biopsy Proven Acute Rejections (BPAR), Death or Graft Loss and of the Individual Components	Week 80	Efficacy failure (biopsy proven acute rejection (BPAR), graft loss, or death
Number of Participants With Fibrosis Progression (Increase in Ishak-Knodell (IK) Score by at Least One Point From the Baseline)	Week 80	Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite, Participants showing an increase of Ishak Knodell fibrosis score by at least one level (increase of ≥1)
Number of Participants of Rapid Viral Response (RVR)	Week 4	RVR defined as non-detectable HCV RNA 4 weeks after initiation of antiviral treatment. The HCV RNA detection limit was \<15 IU/ml (\<1.18 log IU/ml)
Number of Participants of Early Viral Response (EVR)	Week 12	EVR defined as non-detectable HCV RNA or a ≥2 logs reduction of HCV RNA at 12 weeks after initiation of antiviral treatment. The HCV RNA detection limit was \<15 IU/ml (\<1.18 log IU/ml)
Number of Participants for the End of Treatment Response (ETR)	Week 80	ETR defined as non-detectable HCV RNA at the completion of AV treatment. The HCV RNA detection limit was \<15 IU/ml (\<1.18 log IU/ml)
Number of Participants of True Non-responder Rate	Week 80	Defined as failure to achieve at least a 2 log reduction of Hepatitis C virus (HCV) RNA. The HCV RNA detection limit was \<15 IU/ml (\<1.18 log IU/ml)
Number of Participants for Relapse Rate	Week 24	Defined as reappearance of detectable Hepatitis C Virus (HCV) RNA at 24 weeks after completion of antiviral treatment when HCV RNA was undetectable at the end of treatment. The HCV RNA detection limit was \<15 IU/ml (\<1.18 log IU/ml)
Number of Participants With Dose Reduction or Discontinuation of Antiviral (AV) Therapy Due to Poor Tolerability at Any Time During the Study for Any Reason	Week 80	Defined as number of patients with dose reduction or discontinuation of AV therapy due to poor tolerability

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Birmingham, United Kingdom