Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C After Liver Transplantation (LADR)
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ClinicalTrials.gov Identifier: NCT00135798 |
Recruitment Status
:
Completed
First Posted
: August 26, 2005
Results First Posted
: April 4, 2013
Last Update Posted
: April 23, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C | Drug: LADR Treatment | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 79 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: LADR Treatment, Genotypes 1,4,6
Subjects randomized to low accelerating dose regimen (LADR) treatment
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Drug: LADR Treatment
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. Other Names:
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No Intervention: Standard care
Subjects randomized to Standard Care group, Genotypes 1,4,6
|
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Experimental: LADR treatment, Genotypes 2,3
Subjects randomized to low accelerating dose regimen (LADR) treatment.
|
Drug: LADR Treatment
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. Other Names:
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- Patients Who Are Negative for Hepatitis C Virus (HCV) RNA at 3 Months Post-transplant: Intent-to-Treat Analysis (ITT) [ Time Frame: 3 months post-transplant ]Post-transplant virologic response (pTVR) defined as undetectable HCV RNA at week 12 after liver transplantation.
- Patients Who Are Negative for HCV RNA at 3 Months Post-transplant: Per-Protocol Analysis (PP) [ Time Frame: 3 months post-transplant ]Post-transplant virologic response (pTVR) defined as undetectable HCV RNA at week 12 after liver transplantation, analysed among patients who received treatment.
- Patients With Combined Virologic Response (CVR): Intent-to-Treat Analyses (ITT) [ Time Frame: Pre-transplant and 3 months post-transplant ]Intent-to-Treat (ITT) analyses of all patients. Combined Virologic Response (CVR), which includes both sustained virologic response pre-transplant (SVR) and post-transplant virologic response (pTVR)
- Patients With Combined Virologic Response (CVR): Per-Protocol Analysis (PP) [ Time Frame: Pre-transplant and 3 months post-transplant ]Per-Protocol (PP) analyses of all patients. Combined Virologic Response (CVR)includes both sustained virologic response pre-transplant (SVR) and post-transplant virologic response (pTVR), analysed among patients who received treatment.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult (18 or older)
- LDLT candidate
- HCV RNA positive
- Expected time on treatment is at least 12 weeks
- Candidates for DDLT who are listed for transplantation and meet UNOS criteria for MELD upgrade for HCC
Exclusion Criteria:
- Severe cytopenia (polymorphonuclear (PMN) leukocytes < 750, OR hemoglobin [Hgb] < 10 g/dL, OR platelet count < 35,000/mm3)
- Uncontrolled depression or psychiatric disease characterized by current symptoms of major depression or other psychiatric disease or increase in medication for major depression or other psychiatric disease within the past three months.
- Uncontrolled cardiopulmonary disease characterized by myocardial infarction, coronary artery bypass graft surgery, Percutaneous coronary intervention, or unstable angina within the past three months.
- Uncontrolled autoimmune disease characterized by current symptoms of autoimmune disease or increase in medications within the last three months.
- Autoimmune hepatitis
- Active substance abuse within 6 months of initiation of treatment
- Known intolerance or serious adverse event during prior therapy with interferon or ribavirin
- Prior nonresponse after at least 24 weeks of full dose treatment with peginterferon plus ribavirin
- Laboratory Model for End-Stage Liver Disease (MELD) score >20. Patients with laboratory MELD score 21-25 may be enrolled if deemed appropriate by the site investigator
- Serum creatinine >2.2 mg/dL

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135798
United States, California | |
University of California Los Angeles | |
Los Angeles, California, United States, 90095-7054 | |
University of California San Francisco | |
San Francisco, California, United States, 94143-0538 | |
United States, Colorado | |
University of Colorado | |
Denver, Colorado, United States, 80262 | |
United States, Illinois | |
Northwestern University Division of Transplantation | |
Chicago, Illinois, United States, 60611 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, Pennsylvania | |
University of Pennsylvania Hospital | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States, 22908 | |
Virginia Commonwealth University | |
Richmond, Virginia, United States, 23219 |
Study Chair: | Gregory T. Everson, MD | University of Colorado, Denver | |
Study Director: | James Everhart, MD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Additional Information:
Publications of Results:
Other Publications:
Responsible Party: | Averell Sherker, Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00135798 History of Changes |
Other Study ID Numbers: |
A2ALL LADR Protocol 62498(IND) U01DK062498 ( U.S. NIH Grant/Contract ) U01DK062536 ( U.S. NIH Grant/Contract ) U01DK062444 ( U.S. NIH Grant/Contract ) U01DK062467 ( U.S. NIH Grant/Contract ) U01DK062483 ( U.S. NIH Grant/Contract ) U01DK062484 ( U.S. NIH Grant/Contract ) U01DK062494 ( U.S. NIH Grant/Contract ) U01DK062496 ( U.S. NIH Grant/Contract ) U01DK062505 ( U.S. NIH Grant/Contract ) U01DK062531 ( U.S. NIH Grant/Contract ) CRADA through NIH-NIDDK ( Other Identifier: Schering-Plough ) CTA through NIH-NIDDK ( Other Identifier: Ortho-Biotech ) HRSA ( Other Identifier: Health Resources and Services Administration ) ASTS ( Other Identifier: American Society of Transplant Surgeons ) |
First Posted: | August 26, 2005 Key Record Dates |
Results First Posted: | April 4, 2013 |
Last Update Posted: | April 23, 2013 |
Last Verified: | April 2013 |
Keywords provided by Averell Sherker, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Hepatitis C Ribavirin PegInterferon alfa2b |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis C Recurrence Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Flaviviridae Infections Disease Attributes Pathologic Processes Peginterferon alfa-2b Ribavirin Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |