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Hepatitis C VirusPhase 4COPILOTNCT00179413

Study of Long-term Peg Intron vs. Colchicine in Non-responders.

A Phase 4 study testing PEG -Intron and Colchicine in people with Hepatitis C Virus and Advanced Fibrosis, run by Beth Israel Deaconess Medical Center at 49 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatitis C Virus, Advanced Fibrosis, Cirrhosis
What is being tested?
PEG -Intron and Colchicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
549 participants
Where
49 sitesUnited States
Study dates
15 Jan 2000to 3 Mar 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • *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.
  • Patients should have had a liver biopsy showing at least Stage 3 disease prior to being considered for this study. A baseline liver biopsy is necessary for inclusion in the study. Baseline liver biopsies can be performed within six months of entering the study.
  • 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.
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  • 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
  • TSH within the normal range (Patients with thyroid disease who are well controlled are eligible if the remainder of the inclusion/exclusion criteria are met)
  • 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.

Who cannot join

  • 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
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  • Autoimmune hepatitis
  • Alcoholic liver disease
  • Obesity induced liver disease
  • Drug related liver disease
  • In addition:
  • Evidence of decompensated liver disease such as a history or presence of ascites, and spontaneous encephalopathy. Patients with past bleeding esophageal varices that have not bled for more than 1 year can be included.
  • Hypersensitivity to alpha interferon
  • Drug related liver disease
  • Hemoglobinopathies (e.g. Thalassaemia, sickle cell disease).
  • Patients with clinically significant retinal abnormalities.
  • Substance abuse, such as alcohol (·> 80 gm/day), I.V. drugs and inhaled drugs. If the patient has a history of substance abuse, to be considered for inclusion into the protocol, the patient must have abstained from using the abused substance for at least 6 months. Patients on methadone will be allowed in the study with no restrictions as is now standard of care in HCV therapy.
  • Patients with a history of organ transplantation will be excluded.
  • Preexisting psychiatric conditions, especially depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded. Patients with a history of mild depression may enter the protocol if they meet the following eligibility criterion and are monitored more intensively.
  • Mild depression: to include either situational depression of a limited period or depressive symptoms, which do not significantly interfere with the patient's work or daily functions.
  • Any patient with an active manic element to his/her previous symptom complex will be excluded.
  • Any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study such as:
  • Pre-existing psychiatric condition, especially severe depression, or a history of severe psychiatric disorder
  • CNS trauma or seizure disorder requiring therapy
  • Significant cardiac dysfunction in the previous 6 months e.g. angina, CCF, hypertension or arrhythmia Patients on treatment are eligible as long as they have been symptom free for the previous 6 months.
  • Poorly controlled diabetes mellitus
  • Chronic pulmonary disease (e.g. COAD)
  • Immunologically mediated diseases (e.g. inflammatory bowel disease, SLE, ITP, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis, severe psoriasis)
  • Clinical gout
  • Patients with clinically significant retinal abnormalities
  • Patients with organ transplants
  • Any other condition, which in the view of the investigator, would make the patient unsuitable for enrolment, or could interfere with the patient participating in and completing the protocol are included as well.

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

United States49 sites

  • Austin Gastroenterology

    Austin, Texas, 78745

  • 34th Street Community Health Center

    Bakersfield, California, 93301-1645

  • Digestive Disease Associates

    Baltimore, Maryland, 21229

  • Birmingham Gastroenterology Associates

    Birmingham, Alabama, 35209

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Bach and Godofsky Infectious Disease

    Bradenton, Florida, 34205

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • University of Colorado Health Sciences Center

    Denver, Colorado, 80220

  • Wayne State University/Haper Hospital

    Detroit, Michigan, 48601

  • Digestive Health Services

    Downers Grove, Illinois, 60515

  • VA New Jersey Healthcare System

    East Orange, New Jersey, 07018

  • Atlantic Gastroenterology

    Egg Harbor, New Jersey, 08234

  • Hampshire Gastroenterology

    Florence, Massachusetts, 01062

  • Florham Park Endoscopy Center

    Florham Park, New Jersey, 07932

  • Dr. Sam Moskowitz, MD, PC

    Forest Hills, New York, 11375

  • G.I. and Liver Associates

    Granbury, Texas, 76048

  • Southern Clinical Research Consultants

    Hollywood, Florida, 33021

  • Gastroenterology Associates

    Kansas City, Missouri, 64131

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • UAMS Medical Center

    Little Rock, Arkansas, 72205

  • Bruce Stein, MD

    Manchester, Connecticut, 06040

  • Medical Center of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Gastroenterology Division Veterans Affairs Medical Center

    Minneapolis, Minnesota, 55417

  • Nashville Gastroenterology Specialists Incorporated

    Nashville, Tennessee, 37211

  • Connecticut Gastroenterology Consultants

    New Haven, Connecticut, 06510

  • Liberty Medical, LLP

    New York, New York, 10003

  • Metro Medical

    New York, New York, 10011

  • Columbia University

    New York, New York, 10032

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Minnesota Gastroenterology

    Plymouth, Minnesota, 55446

  • Peter Varunok, MD

    Poughkeepsie, New York, 12601

  • University Gastroenterologists

    Providence, Rhode Island, 02905

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Kaiser Permanende-GI Department

    Sacramento, California, 95825

  • Health Science Center

    Salt Lake City, Utah, 84132

  • Digestive Disease Center

    San Antonio, Texas, 78205

  • Texas Transplant Institute

    San Antonio, Texas, 78229

  • Gastroenterology Associates

    San Diego, California, 92115

  • Northern New Mexico Gastroenterology

    Santa Fe, New Mexico, 87505

  • Guthrie Research Foundation

    Sayre, Pennsylvania, 18840

  • Gastroenterology Associates of South Florida

    South Miami, Florida, 33143

  • Upstate Medical Center

    Syracuse, New York, 13210

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007-2197

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5001

  • Fallon Clinic

    Worcester, Massachusetts, 01608

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

We are proposing a randomized trial of Peg-Intron 0.5mcg per kg weekly versus colchicine 0.6mg bid in prior non-responders to Interferon, Rebetron, PegIntron, or PegIntron \& Ribavirin or any third agent such as Pegasys, CellCept, Amantadine with advanced fibrosis/cirrhosis. The specific aims of this proposal are to evaluate the role of long term Peg-Intron therapy on the natural history of patients with advanced chronic HCV infection with a primary focus on prevention of hepatic decompensation, progression of fibrosis and hepatoma development.

The study design will focus on 3 monthly clinical evaluation for decompensation of liver function, rigorous clinical screening for development of hepatocellular cancer and liver biopsies for determination of progression of liver fibrosis every second year.

Being tested
PEG -Intron, Colchicine
Keywords
hepatitis C, cirrhosis, interferon, colchicine
Medical subject headings
Hepatitis C, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEG -IntronDrug

    Also called PEG interferon Alfa-2b 0.5mcg/kg weekly

  • ColchicineDrug

    0.6mg twice a day

Study groups in NCT00179413
Study groupRoleWhat they receive
PEG-IntronActive comparatorPEG-Intron 0.5mcg/kg once a week SC
Receives: Drug: PEG -Intron
ColchicineActive comparator0.6mg twice a day
Receives: Drug: Colchicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 years

Secondary outcomes (2)

  1. Evaluation of Safety and Tolerability of Long Term Maintenance PEG-Intron in Patients With Cirrhosis

    Defined as the number of patients who discontinued therapy due to an adverse event side

    Measured: 4 years

  2. Development of Portal Hypertension

    Number of patients who develop endoscopic evidence of varices over 4 year period

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study start15 Jan 2000
  3. Primary completion31 Dec 2009
  4. Study completion3 Mar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
549 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00179413
Sponsor's protocol ID
2001P000002
Acronym
COPILOT
Status last verified
Jun 2017
First submitted
10 Sep 2005
Last updated
11 Jul 2017
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PEG -Intron and Colchicine in people with Hepatitis C Virus and Advanced Fibrosis, run by Beth Israel Deaconess Medical Center at 49 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of the Effect of PEG-Intron 0.5mg Per kg Weekly sc Versus Colchicine 0.6mg Bid Daily on: (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00179413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.

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