Study of Long-term Peg Intron vs. Colchicine in Non-responders.
COPILOT
Phase IV Study of Long Term Peg-Intron for Patients Who Have Failed to Respond to Rebetron/Interferon With Advanced Fibrosis and Cirrhosis Secondary to Hepatitis C- The Copilot Trial
1 other identifier
interventional
549
1 country
49
Brief Summary
In this study Peg-Intron will be tested to see if it will give better results than Colchicine. At this time, there is currently no recommended maintenance treatment for patients who have failed to respond to Interferon/Rebetron/Peg Intron and have advanced fibrosis. The purpose of this study is to compare two treatments to slow down the progression of liver disease and to prevent liver failure and liver cancer. The treatment will not cure Hepatitis C, but is being evaluated to see if it can slow down disease progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2000
Longer than P75 for phase_4
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2000
CompletedFirst Submitted
Initial submission to the registry
September 10, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2010
CompletedResults Posted
Study results publicly available
July 11, 2017
CompletedJuly 11, 2017
June 1, 2017
10 years
September 10, 2005
April 13, 2017
June 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determination of the Effect of PEG-Intron 0.5mg Per kg Weekly sc Versus Colchicine 0.6mg Bid Daily on:
number of patients with a liver related outcomes including: mortality, liver transplant, variceal or portal hypertensive bleeding,Development of jaundice, ascites or encephalopathy with an increase in CPT of \> 2 points and development of hepatoma
4 years
Secondary Outcomes (2)
Evaluation of Safety and Tolerability of Long Term Maintenance PEG-Intron in Patients With Cirrhosis
4 years
Development of Portal Hypertension
4 years
Study Arms (2)
PEG-Intron
ACTIVE COMPARATORPEG-Intron 0.5mcg/kg once a week SC
Colchicine
ACTIVE COMPARATOR0.6mg twice a day
Interventions
Eligibility Criteria
You may qualify if:
- \*Adult male or female, age 18 to 75 years
- HCV RNA positive by PCR
- Previous treatment with at least three months of interferon or interferon / Ribavirin. Patients should have had no interferon for at least 2 months prior to enrollment.
- Non-responders are identified by failure to clear virus by PCR after a minimum 3-month course of treatment and who have been off treatment for at least 2 months with a positive PCR for HCV prior to entry into the current study, 2) Partial responders have a reduction of 1 long in HCV RNA, but the virus is still detectable, 3) Breakthrough patients have been negative on treatment, but virus appeared while still on treatment, 4) Relapsers are defined as negative PCR at some point during treatment, but virus reoccurred or was detectable by HCV PCR when treatment stopped.
- In patients with cirrhosis and endoscopic evidence of portal hypertension, a biopsy within the last 2 years is acceptable as the baseline biopsy. For patients with established cirrhosis on liver biopsy and no portal hypertension, a biopsy within 12 months can be used as the baseline biopsy if it is available for evaluation by the Pathology core. All these patients will still require liver biopsy at 2 years and 4 years. The decision to biopsy at 2 and 4 years is also a clinical decision and in the presence of clinical progression or coagulopathy, or where there may be a risk from liver biopsy, the Investigator should call the PI, Dr. Afdhal for a waiver of biopsy. Patients with Ishak Stage 3 and 4 require a biopsy within 6 months of randomization.
- Hemoglobin \>= 11 g/dl in males and 10 g/dl in females
- Neutrophil count \> 1,500/mm3
- Platelets \> 50, 000/mm3
- Platelet count: For standard dose of PEG-Intron 0.5mcg/kg platelet count must be greater than 70,000. Patients with platelet count 50 - 70,000 can start at 0.25mcg/kg for weeks 0 - 4. If platelets fall to less than 30,000, stop treatment. If platelets remain \> 50,000 at week 4, PEG-Intron can be increased to 0.5mcg/kg. Patients randomized to Colchicine with platelets 50,000 - 70,000 can be started at standard dose 0.6mg bid po with standard dose reduction.
- Prothrombin time \<= 3secs prolonged compared to control or an equivalent INR \< 1.5
- Total bilirubin \< 3gm/dL
- Fasting blood sugar \<= 115 mg/dl or within 20% of the upper limit of normal for non-diabetic patients
- Albumin (\> 2.8mg/dl)
- Serum creatinine \< 1.4 mg/dL
You may not qualify if:
- HIV negative.
- HBsAg negative
- Childs Pugh score of less than or equal to 7
- Serum positive for anti-hepatitis C antibodies or HCV RNA.
- Alpha-fetoprotein \< 100ng/ml with ultrasound negative for focal mass or HCC. For any patient with an Alpha-fetoprotein \>100 ng/ml either a triple phase contrast CT scan or MRI with gadolinium must show no focal mass or evidence of HCC
- Ultrasound with no evidence of focal mass suggestive of hepatoma (within 6 months of informed consent).
- Documentation that sexually active female patients of childbearing potential are practicing adequate contraception during the treatment period. A urine pregnancy test obtained at entry prior to the initiation of treatment must be negative. Female patients must not be breast-feeding. Documentation that sexually active male patients are practicing acceptable methods of contraception during the treatment period.
- Written informed consent specific for this protocol has been obtained prior to entry.
- Any cause of liver disease based on patient history and biopsy (where applicable) other than chronic hepatitis C including but not limited to:
- Co-infection with hepatitis B or HIV
- Hemochromatosis (confirmed by genetic testing)
- Alpha-1 antitrypsin deficiency
- Wilson's disease
- Renal or liver transplant patients
- Autoimmune hepatitis
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Israel Deaconess Medical Centerlead
- Schering-Ploughcollaborator
Study Sites (49)
Birmingham Gastroenterology Associates
Birmingham, Alabama, 35209, United States
UAMS Medical Center
Little Rock, Arkansas, 72205, United States
34th Street Community Health Center
Bakersfield, California, 93301-1645, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Kaiser Permanende-GI Department
Sacramento, California, 95825, United States
Gastroenterology Associates
San Diego, California, 92115, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80220, United States
Danbury Hospital
Danbury, Connecticut, 06810, United States
Bruce Stein, MD
Manchester, Connecticut, 06040, United States
Connecticut Gastroenterology Consultants
New Haven, Connecticut, 06510, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007-2197, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001, United States
Bach and Godofsky Infectious Disease
Bradenton, Florida, 34205, United States
Southern Clinical Research Consultants
Hollywood, Florida, 33021, United States
Gastroenterology Associates of South Florida
South Miami, Florida, 33143, United States
Digestive Health Services
Downers Grove, Illinois, 60515, United States
Digestive Disease Associates
Baltimore, Maryland, 21229, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Hampshire Gastroenterology
Florence, Massachusetts, 01062, United States
Fallon Clinic
Worcester, Massachusetts, 01608, United States
Wayne State University/Haper Hospital
Detroit, Michigan, 48601, United States
Gastroenterology Division Veterans Affairs Medical Center
Minneapolis, Minnesota, 55417, United States
Minnesota Gastroenterology
Plymouth, Minnesota, 55446, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Gastroenterology Associates
Kansas City, Missouri, 64131, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
VA New Jersey Healthcare System
East Orange, New Jersey, 07018, United States
Atlantic Gastroenterology
Egg Harbor, New Jersey, 08234, United States
Florham Park Endoscopy Center
Florham Park, New Jersey, 07932, United States
Northern New Mexico Gastroenterology
Santa Fe, New Mexico, 87505, United States
Dr. Sam Moskowitz, MD, PC
Forest Hills, New York, 11375, United States
Liberty Medical, LLP
New York, New York, 10003, United States
Metro Medical
New York, New York, 10011, United States
Columbia University
New York, New York, 10032, United States
Peter Varunok, MD
Poughkeepsie, New York, 12601, United States
Upstate Medical Center
Syracuse, New York, 13210, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Guthrie Research Foundation
Sayre, Pennsylvania, 18840, United States
University Gastroenterologists
Providence, Rhode Island, 02905, United States
Roger Williams Medical Center
Providence, Rhode Island, 02908, United States
Nashville Gastroenterology Specialists Incorporated
Nashville, Tennessee, 37211, United States
Austin Gastroenterology
Austin, Texas, 78745, United States
G.I. and Liver Associates
Granbury, Texas, 76048, United States
Digestive Disease Center
San Antonio, Texas, 78205, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Health Science Center
Salt Lake City, Utah, 84132, United States
Medical Center of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Nezam Afdhal
- Organization
- BIDMC
Study Officials
- PRINCIPAL INVESTIGATOR
Nezam H Afdhal, MD
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, Part-time
Study Record Dates
First Submitted
September 10, 2005
First Posted
September 16, 2005
Study Start
January 15, 2000
Primary Completion
December 31, 2009
Study Completion
March 3, 2010
Last Updated
July 11, 2017
Results First Posted
July 11, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share