CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 79 enrolled
Drug / intervention
LADR Treatmentdrug
Likely dose
Peginterferon alfa-2b 0.75–1.5 µg/kg/week and ribavirin 600–1000 mg/day (escalated per protocol)AI-extracted
Key inclusion· 5
  • ✓Age 18 or older
  • ✓Living donor liver transplant (LDLT) candidate
  • ✓HCV RNA positive
  • ✓Expected treatment duration of at least 12 weeks
Key exclusion· 10
  • ✕Severe cytopenia: PMN <750/mm³, hemoglobin <10 g/dL, or platelets <35,000/mm³
  • ✕Uncontrolled depression or psychiatric disease with current symptoms or medication increase within past 3 months
  • ✕Uncontrolled cardiopulmonary disease: MI, CABG, PCI, or unstable angina within past 3 months
  • ✕Uncontrolled autoimmune disease with current symptoms or medication increase within past 3 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00135798
NCT00135798Phase 2Completed
CompareCT.gov

The Adult-to-adult Living Donor Liver Transplantation Cohort Study (A2ALL) Low Accelerated Dosing Regimen (LADR) Protocol: Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C Virus (HCV) After Liver Transplantation

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Aug 26, 2005·Updated Apr 23, 2013

In Brief

A Phase 2 clinical trial evaluating LADR Treatment for Hepatitis C. Completed, enrolled 79 participants across 8 sites.

Detailed Summary

The purpose of this study is to learn if pre-liver transplant treatment, using peginterferon plus ribavirin, will clear hepatitis C virus (HCV) RNA from the blood in HCV-infected recipients and reduce the risk of recurrent HCV and allograft hepatitis following liver transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesUnited States
CollaboratorsSchering-Plough, Ortho Biotech Clinical Affairs, L.L.C.

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 26, 2005
Enrollment StartSep 1, 2005
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.8 years ago

Interventions

LADR Treatmentdrug

PEG-Intron (peginterferon alfa-2b (PEGIFN)) Redipen; Rebetol (ribavirin (RBV) United States Pharmacopeia (USP)) Capsules: Treatment was initiated with PEGIFN 0.75 µg/kg/week and RBV 600 mg/day. Dose escalations were performed at weeks 1 (PEGIFN 1.5 µg/kg/week and RBV 800 mg/day), 2 (RBV 1.0 g/day), and 3 (RBV 1.2 g/day for patients who weighed more then 75 kg) based upon patient tolerance and weekly blood counts. Once a patient reached the target RBV dose of 1-1.2 g/day (approximately 10.6 to 13.2 mg/kg/day), no further increases in RBV dose were made. Subsequent doses of PEGIFN and RBV were adjusted based upon adverse events, patient tolerability, and blood counts. If the highest tolerated dose of PEGIFN was \<0.5 ug/kg, PEGIFN was permanently discontinued.