Chronic Hepatitis CPhase 2NCT00028275
Gamma Interferon Therapy for Chronic Hepatitis C
A Phase 2 study testing Gamma Interferon 1b in people with Chronic Hepatitis C, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This study will test whether gamma interferon is effective in treating chronic hepatitis C infection-a long-lasting viral infection affecting the liver. One-third of patients with hepatitis C infection develop cirrhosis of the liver, which can lead to liver failure or liver cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Gamma Interferon 1b
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Nov 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 18 years or above, male or female.
- Serum alanine or asparate aminotransferase activities that are above the upper limit of normal (ALT greater than 41 or AST greater than 31 IU/L).
- Presence of anti-HCV in serum.
- Presence of HCV RNA genotype1 in serum at levels above 10,000 copies/ml.
- Previous adequate therapy with alpha interferon and ribavirin without a sustained virological response. An adequate course of therapy is defined as at least 24 weeks of alpha interferon in starting doses of 3 million units thrice weekly and ribavirin in starting doses of at least 1000 mg daily. Patients who initiated therapy at these doses, but required dose modification due to side effects will also be eligible.
- Written informed consent.
Who cannot join
- Decompensated liver disease, as marked by bilirubin greater than 4 mg%, albumin less than 3.0 gm%, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Patients with ALT levels greater than 1000 U/L (greater than 25 times ULN) will not be enrolled but may be followed until three determinations are below this level.
- Pregnancy, or in women of child-bearing potential or in spouses of such women, inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermacide, or birth control pills, or an intrauterine device.
- Significant systemic or major illnesses other than liver disease, including congestive heart failure, ischemic heart disease, angina pectoris, cerebrovascular disease, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression.
- Pre-existing, severe bone marrow compromise; anemia (hematocrit less than 34%), neutropenia (less than 1000 polymorphonuclear cells/mm(3)) or thrombocytopenia (less than 70,000 cells/mm(3)).
- Evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, Wilson's disease, alcoholic liver disease, hemochromatosis, alpha-1-antitrypsin deficiency).
- Active substance abuse, such as alcohol, inhaled or injection drugs within the previous six months.
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- Serious autoimmune disease that, in the opinion of the investigators, might be worsened by interferon therapy, such as lupus erythematous, rheumatoid arthritis or Crohn's disease.
- Evidence of hepatocellular carcinoma; either alphafetoprotein (AFP) levels greater than 50 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.
- Human immunodeficiency virus infection, as shown by presence of anti-HIV.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, 20892
About this study
Official title: Pilot Studies of Gamma Interferon Therapy for Chronic Hepatitis C
This study will test whether gamma interferon is effective in treating chronic hepatitis C infection-a long-lasting viral infection affecting the liver. One-third of patients with hepatitis C infection develop cirrhosis of the liver, which can lead to liver failure or liver cancer. The current treatment for hepatitis C infection is pegylated alpha interferon (peginterferon) plus ribavirin; however, this treatment is successful in only about half of patients. Gamma interferon works similarly to alpha interferon, but through different pathways, and therefore might be helpful in patients who do not respond to alpha interferon.
Patients 18 years of age and older with chronic hepatitis C infection, genotype 1, who did not respond to alpha interferon and ribavirin therapy may be eligible for this study. (Genotype 1 is a strain of hepatitis C virus that has a lower treatment success rate.)
Read more
Potential participants will be admitted to the NIH Clinical Center for 2 to 3 days for a medical evaluation to determine eligibility for the study and, if enrolled, to begin gamma interferon therapy. Screening will include a medical history and physical examination, blood and urine tests, and possibly chest X-ray, abdominal ultrasound, and psychiatric evaluation.
Participants will receive injections of gamma interferon under the skin 3 times a week for 4 weeks (a total of 12 injections). They will be randomly assigned to receive either 100 or 200 micrograms of drug per injection. Blood will be drawn just before the first injection and then 6, 12, 24 and 48 hours later to monitor changes in the levels of hepatitis C virus and immune responses to treatment. The amount and rapidity of decrease in virus will be compared with what occurs with alpha interferon treatment to define the relative effectiveness of gamma interferon. (Patients may leave the hospital at any time after the first day, but must return in time for the final blood test.)
Patients will be seen in the clinic each week during treatment to report symptoms and drug side effects and to have blood drawn for routine tests and viral levels. After the 4-week treatment is completed, patients will return for follow-up visits at weeks 6 and 8 for routine blood tests.
Read the detailed description
We will treat 20 patients with chronic hepatitis C using gamma interferon 1b in doses of either 100 or 200 mcg thrice weekly for four weeks while monitoring them at regular, timed intervals for hepatitis C virus (HCV) RNA levels and immunological responses to HCV antigens. Patients with chronic hepatitis C will be eligible if they have failed to have responded to a previous course of alpha interferon and ribavirin and have raised serum aminotransferase levels, HCV genotype 1 and HCV RNA in serum in levels greater than 10,000 copies/ml. The 20 patients will include 10 patients who were treated and did not become HCV RNA negative during therapy (Group A: non-responders) and 10 who were treated and became HCV RNA negative during therapy but relapsed thereafter (Group B: relapsers). After a medical evaluation and monitoring for HCV RNA levels, patients will be randomized to receive either 100 or 200 mcg of gamma interferon 1b (provided by InterMune Pharmaceuticals, Inc) subcutaneously three times weekly for 4 weeks. Patients will have blood tested for HCV RNA levels at 0, 6, 12, 18, 24, and 48 hours after the initial injection and then weekly during treatment, followed by 2 and 4 weeks thereafter. T cell responses to HCV antigens will be assessed before treatment, after 4 weeks of therapy and again 4 weeks thereafter. Patients will also be monitored for side effects and changes in routine liver tests and complete blood counts.
This is a pilot study in a small number of patients which is aimed at assessing whether gamma interferon has antiviral and immunological effects against hepatitis C, whether these effects appear to be dose related, and whether they are similar in timing and degree to those of alpha interferon. Demonstration of an antiviral effect would lead to more extensive trials in larger numbers of patients, treated for longer periods.
- Conditions
- Chronic Hepatitis C
- Being tested
- Gamma Interferon 1b
- Keywords
- Hepatitis C Virus, Cirrhosis, Antiviral Agents, Viral Resistance, Alpha Interferon, Hepatitis C, Hepatitis
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Fibrosis, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma Interferon 1bDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2001 (estimated)
- Study startDec 2001
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Enrolment
- 20 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028275
- Sponsor's protocol ID
- 020072
- Other IDs
- 02-DK-0072
- Status last verified
- Nov 2003
- First submitted
- 18 Dec 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Liang TJ, Rehermann B, Seeff LB, Hoofnagle JH. Pathogenesis, natural history, treatment, and prevention of hepatitis C. Ann Intern Med. 2000 Feb 15;132(4):296-305. doi: 10.7326/0003-4819-132-4-200002150-00008.
PubMed 10681285Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. doi: 10.1056/NEJM200107053450107. No abstract available.
PubMed 11439948Kiyosawa K, Sodeyama T, Tanaka E, Gibo Y, Yoshizawa K, Nakano Y, Furuta S, Akahane Y, Nishioka K, Purcell RH, et al. Interrelationship of blood transfusion, non-A, non-B hepatitis and hepatocellular carcinoma: analysis by detection of antibody to hepatitis C virus. Hepatology. 1990 Oct;12(4 Pt 1):671-5. doi: 10.1002/hep.1840120409.
PubMed 2170265
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Studies of Gamma Interferon Therapy for Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00028275
- Acronym / sponsor ID
- 020072
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C Virus, Cirrhosis, Antiviral Agents, Viral Resistance, Alpha Interferon, Hepatitis C, Hepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Dec 2001
- Study completion
- Nov 2003
- First posted
- 19 Dec 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether gamma interferon is effective in treating chronic hepatitis C infection-a long-lasting viral infection affecting the liver. One-third of patients with hepatitis C infection develop cirrhosis of the liver, which can lead to liver failure or liver cancer. The current treatment for hepatitis C infection is pegylated alpha interferon (peginterferon) plus ribavirin; however, this treatment is successful in only about half of patients. Gamma interferon works similarly to alpha interferon, but through different pathways, and therefore might be helpful in patients who do not respond to alpha interferon.
Patients 18 years of age and older with chronic hepatitis C infection, genotype 1, who did not respond to alpha interferon and ribavirin therapy may be eligible for this study. (Genotype 1 is a strain of hepatitis C virus that has a lower treatment success rate.)
Potential participants will be admitted to the NIH Clinical Center for 2 to 3 days for a medical evaluation to determine eligibility for the study and, if enrolled, to begin gamma interferon therapy. Screening will include a medical history and physical examination, blood and urine tests, and possibly chest X-ray, abdominal ultrasound, and psychiatric evaluation.
Participants will receive injections of gamma interferon under the skin 3 times a week for 4 weeks (a total of 12 injections). They will be randomly assigned to receive either 100 or 200 micrograms of drug per injection. Blood will be drawn just before the first injection and then 6, 12, 24 and 48 hours later to monitor changes in the levels of hepatitis C virus and immune responses to treatment. The amount and rapidity of decrease in virus will be compared with what occurs with alpha interferon treatment to define the relative effectiveness of gamma interferon. (Patients may leave the hospital at any time after the first day, but must return in time for the final blood test.)
Patients will be seen in the clinic each week during treatment to report symptoms and drug side effects and to have blood drawn for routine tests and viral levels. After the 4-week treatment is completed, patients will return for follow-up visits at weeks 6 and 8 for routine blood tests.
Detailed description
We will treat 20 patients with chronic hepatitis C using gamma interferon 1b in doses of either 100 or 200 mcg thrice weekly for four weeks while monitoring them at regular, timed intervals for hepatitis C virus (HCV) RNA levels and immunological responses to HCV antigens. Patients with chronic hepatitis C will be eligible if they have failed to have responded to a previous course of alpha interferon and ribavirin and have raised serum aminotransferase levels, HCV genotype 1 and HCV RNA in serum in levels greater than 10,000 copies/ml. The 20 patients will include 10 patients who were treated and did not become HCV RNA negative during therapy (Group A: non-responders) and 10 who were treated and became HCV RNA negative during therapy but relapsed thereafter (Group B: relapsers). After a medical evaluation and monitoring for HCV RNA levels, patients will be randomized to receive either 100 or 200 mcg of gamma interferon 1b (provided by InterMune Pharmaceuticals, Inc) subcutaneously three times weekly for 4 weeks. Patients will have blood tested for HCV RNA levels at 0, 6, 12, 18, 24, and 48 hours after the initial injection and then weekly during treatment, followed by 2 and 4 weeks thereafter. T cell responses to HCV antigens will be assessed before treatment, after 4 weeks of therapy and again 4 weeks thereafter. Patients will also be monitored for side effects and changes in routine liver tests and complete blood counts.
This is a pilot study in a small number of patients which is aimed at assessing whether gamma interferon has antiviral and immunological effects against hepatitis C, whether these effects appear to be dose related, and whether they are similar in timing and degree to those of alpha interferon. Demonstration of an antiviral effect would lead to more extensive trials in larger numbers of patients, treated for longer periods.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or above, male or female.
- Serum alanine or asparate aminotransferase activities that are above the upper limit of normal (ALT greater than 41 or AST greater than 31 IU/L).
- Presence of anti-HCV in serum.
- Presence of HCV RNA genotype1 in serum at levels above 10,000 copies/ml.
- Previous adequate therapy with alpha interferon and ribavirin without a sustained virological response. An adequate course of therapy is defined as at least 24 weeks of alpha interferon in starting doses of 3 million units thrice weekly and ribavirin in starting doses of at least 1000 mg daily. Patients who initiated therapy at these doses, but required dose modification due to side effects will also be eligible.
Key exclusion criteria (9 listed)
- Decompensated liver disease, as marked by bilirubin greater than 4 mg%, albumin less than 3.0 gm%, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Patients with ALT levels greater than 1000 U/L (greater than 25 times ULN) will not be enrolled but may be followed until three determinations are below this level.
- Pregnancy, or in women of child-bearing potential or in spouses of such women, inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermacide, or birth control pills, or an intrauterine device.
- Significant systemic or major illnesses other than liver disease, including congestive heart failure, ischemic heart disease, angina pectoris, cerebrovascular disease, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression.
- Pre-existing, severe bone marrow compromise; anemia (hematocrit less than 34%), neutropenia (less than 1000 polymorphonuclear cells/mm(3)) or thrombocytopenia (less than 70,000 cells/mm(3)).
- Evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, Wilson's disease, alcoholic liver disease, hemochromatosis, alpha-1-antitrypsin deficiency).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamma Interferon 1b | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 10681285Liang TJ, Rehermann B, Seeff LB, Hoofnagle JH. Pathogenesis, natural history, treatment, and prevention of hepatitis C. Ann Intern Med. 2000 Feb 15;132(4):296-305. doi: 10.7326/0003-4819-132-4-200002150-00008.
- Background: PubMed 11439948Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. doi: 10.1056/NEJM200107053450107. No abstract available.
- Background: PubMed 2170265Kiyosawa K, Sodeyama T, Tanaka E, Gibo Y, Yoshizawa K, Nakano Y, Furuta S, Akahane Y, Nishioka K, Purcell RH, et al. Interrelationship of blood transfusion, non-A, non-B hepatitis and hepatocellular carcinoma: analysis by detection of antibody to hepatitis C virus. Hepatology. 1990 Oct;12(4 Pt 1):671-5. doi: 10.1002/hep.1840120409.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gamma Interferon 1b in people with Chronic Hepatitis C, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site 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 6 inclusion and 9 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 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00028275, which also lists 3 linked publications.
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 4 Mar 2008.