Chronic Hepatitis CPhase 4NCT01120795
Pegylated Interferon and Ribavirin in Hepatitis C Patients on Opioid Pharmacotherapy
A Phase 4 study testing Pegylated interferon and ribavirin in people with Chronic Hepatitis C, run by Melbourne Health at 4 sites in Australia.
Trial summary
The purpose of this study is to see if treatment of chronic hepatitis C in people who are on opiate replacement therapy such as methadone or buprenorphine (including patient who still inject drugs) is safe and effective. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Pegylated interferon and ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 4 sitesAustralia
- Study dates
- Feb 2004to Jul 2006
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- on opioid substitution therapy (methadone or buprenorphine)
- serologic evidence of chronic hepatitis C infection determined by a detectable anti-HCV antibody for 6 months or greater with evidence of detectable HCV RNA
- elevated ALT on at least two occasions at least one month apart within the past 6 months, with at least one during the screening period preceding the initiation of study drug dosing.
- HCV treatment-naïve
- Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection (unless contraindicated due to a bleeding disorder)
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- Compensated liver disease (Child-Pugh Grade A clinical classification).
- All fertile males and females receiving ribavirin were required to be using two forms of effective contraception during treatment and during the 6 months after treatment
- Women of child bearing potential were required to have a negative urine or blood pregnancy test documented within the 24-hour period prior to the first dose of study drug
Who cannot join
- Women who were pregnant, breastfeeding or planning a pregnancy
- Male partners of women who were pregnant
- Patients who had previously received therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
- Recipients of any investigational drug 4 weeks or 5 half lives, whichever was longer, prior to the first dose of study drug
- A positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab
- A history or other evidence of a medical condition associated with chronic liver disease other than HCV
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- Haemoglobin <12 g/dL in women or <13 g/dL in men, a neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening and serum creatinine level >1.5 times the upper limit of normal at screening.)
- A history of a severe seizure disorder or current anticonvulsant use
- Patients with a history of immunologically-mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, coronary artery disease, cerebrovascular disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- Patients with a history of thyroid disease which is poorly controlled on prescribed medications
- Evidence of severe retinopathy
- Evidence of excessive substance abuse as judged by the investigator
- Patients with an increased baseline risk for anaemia (e.g. thalassaemia, spherocytosis, history of gastrointestinal bleeding, etc) or for whom anemia would be medically problematic.
- Patients with a history of severe psychiatric disease (defined as acute phase of schizophrenia or bipolar disorder manic, mixed or depressive phase, severe anorexia, history of severe multiple episodes of self harm, currently screening as high or moderate suicide risk, current major depressive episode or current psychosis of any cause at screening)
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Western Hospital
Footscray, Victoria, 3011
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Nepean Hospital
Sydney, New South Wales
St Vincents Hospital
Sydney, New South Wales
About this study
Official title: Pegylated Interferon Alfa-2a Plus Ribavirin for Patients With Chronic Hepatitis c Virus on Opioid Pharmacotherapy: Virological and Psychological Outcomes
The purpose of this study is to see if treatment of chronic hepatitis C in people who are on opiate replacement therapy such as methadone or buprenorphine (including patient who still inject drugs) is safe and effective.
Read the detailed description
It is estimated that in excess of 170 million people worldwide are infected with the hepatitis C virus (HCV) resulting in 1.4 million deaths annually. In developed countries HCV is most commonly transmitted through injecting drug use (IDU) with estimates suggesting up to 80-90% of incident cases are due to unsafe injecting practices. Infection results in chronic infection in around 75% of cases and it is these patients who subsequently develop the life-threatening complications of liver failure and hepatocellular carcinoma due to progressive fibrosis.
Current standard of care consists of a combination of pegylated interferon and ribavirin which results in sustained virological response rates (SVR, defined as undetectable HCV RNA 24 weeks post treatment) in 54-63% of patients. This is strongly dependent on viral genotype with genotype 1 patients achieving lower SVR rates compared to genotype 2 and 3. These therapies are however associated with significant side effects, most notably psychiatric. Depression, anxiety and irritability are common and of concern is the attendant risk of suicidality in patients with a chronic illness in which depression is particularly common. Mood disorders have been reported to occur in up to 50% patients on therapy and can result in dose reductions and discontinuation in 40% and 20% patients respectively.
While more effective therapies have become available for the treatment of chronic HCV, they have not been largely utilised in patients actively injecting. This is due to concerns about potential poor adherence to treatment regimens, reinfection due to ongoing IDU, increased incidence of concomitant alcohol abuse, potential for increased side effects (especially psychiatric), concerns about pregnancy with ribavirin use due to non-adherence to contraception as well as active discrimination by practitioners. There are however considerable potential advantages including: improvement in the health of the infected individual, potential for decreasing the burden of disease to the community with its attendant costs as well as the potential for impact on transmission and its inherent potential public health benefits.
This multicentre study was conducted to determine the response rates as well as the AE profile and the psychiatric impact of therapy in a population with chronic hepatitis C (CHC) who were receiving opiate pharmacotherapy, many of who were still injecting.
- Conditions
- Chronic Hepatitis C
- Being tested
- Pegylated interferon and ribavirin
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated interferon and ribavirinDrug
Also called Pegasys and Copegus
Pegylated interferon 180 ug subcutaneous per week Ribavirin 1000-1200 mg /day for genotype 1 and 800 mg /day orally for genotype non 1 Duration: 48 weeks for genotype 1 and 24 weeks for gentoype non 1
Pegylated interferon and ribavirinDrug
Also called Pegasys and Copegus
Pegylated interferon 180 ug/ week subcutaneously Ribavrin 1000-1200 mg /day for genotype 1 and 800 mg/day orally for genotype 2 and 3 Treatment duration 48 weeks for genotype 1 and 24 weeks for genotypes 2 and 3
| Study group | Role | What they receive |
|---|---|---|
| pegylated interferon and ribavirin | Experimental | Anti hepatitis C agents Receives: Drug: Pegylated interferon and ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response
Measured: 24 weeks post cessation of HCV therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startFeb 2004
- Primary completionJan 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- The University of New South Wales, St Vincent's Hospital, Sydney, Western Hospital, Australia, Monash University, Hoffmann-La Roche
- Investigators
- Joseph J Sasadeusz, MBBS, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120795
- Sponsor's protocol ID
- HREC 2000.175
- Status last verified
- May 2010
- First submitted
- 6 May 2010
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Sasadeusz JJ, Dore G, Kronborg I, Barton D, Yoshihara M, Weltman M. Clinical experience with the treatment of hepatitis C infection in patients on opioid pharmacotherapy. Addiction. 2011 May;106(5):977-84. doi: 10.1111/j.1360-0443.2010.03347.x.
PubMed 21205057
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pegylated Interferon Alfa-2a Plus Ribavirin for Patients With Chronic Hepatitis c Virus on Opioid Pharmacotherapy: Virological and Psychological Outcomes
- ClinicalTrials.gov ID
- NCT01120795
- Acronym / sponsor ID
- HREC 2000.175
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- The University of New South Wales, St Vincent's Hospital, Sydney, Western Hospital, Australia, Monash University, Hoffmann-La Roche
- Study start
- Feb 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 11 May 2010 (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.
The purpose of this study is to see if treatment of chronic hepatitis C in people who are on opiate replacement therapy such as methadone or buprenorphine (including patient who still inject drugs) is safe and effective.
Detailed description
It is estimated that in excess of 170 million people worldwide are infected with the hepatitis C virus (HCV) resulting in 1.4 million deaths annually. In developed countries HCV is most commonly transmitted through injecting drug use (IDU) with estimates suggesting up to 80-90% of incident cases are due to unsafe injecting practices. Infection results in chronic infection in around 75% of cases and it is these patients who subsequently develop the life-threatening complications of liver failure and hepatocellular carcinoma due to progressive fibrosis.
Current standard of care consists of a combination of pegylated interferon and ribavirin which results in sustained virological response rates (SVR, defined as undetectable HCV RNA 24 weeks post treatment) in 54-63% of patients. This is strongly dependent on viral genotype with genotype 1 patients achieving lower SVR rates compared to genotype 2 and 3. These therapies are however associated with significant side effects, most notably psychiatric. Depression, anxiety and irritability are common and of concern is the attendant risk of suicidality in patients with a chronic illness in which depression is particularly common. Mood disorders have been reported to occur in up to 50% patients on therapy and can result in dose reductions and discontinuation in 40% and 20% patients respectively.
While more effective therapies have become available for the treatment of chronic HCV, they have not been largely utilised in patients actively injecting. This is due to concerns about potential poor adherence to treatment regimens, reinfection due to ongoing IDU, increased incidence of concomitant alcohol abuse, potential for increased side effects (especially psychiatric), concerns about pregnancy with ribavirin use due to non-adherence to contraception as well as active discrimination by practitioners. There are however considerable potential advantages including: improvement in the health of the infected individual, potential for decreasing the burden of disease to the community with its attendant costs as well as the potential for impact on transmission and its inherent potential public health benefits.
This multicentre study was conducted to determine the response rates as well as the AE profile and the psychiatric impact of therapy in a population with chronic hepatitis C (CHC) who were receiving opiate pharmacotherapy, many of who were still injecting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pegylated interferon and ribavirin | Experimental | Drug: Pegylated interferon and ribavirinAnti hepatitis C agents |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older
- on opioid substitution therapy (methadone or buprenorphine)
- serologic evidence of chronic hepatitis C infection determined by a detectable anti-HCV antibody for 6 months or greater with evidence of detectable HCV RNA
- elevated ALT on at least two occasions at least one month apart within the past 6 months, with at least one during the screening period preceding the initiation of study drug dosing.
- HCV treatment-naïve
Key exclusion criteria (14 listed)
- Women who were pregnant, breastfeeding or planning a pregnancy
- Male partners of women who were pregnant
- Patients who had previously received therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
- Recipients of any investigational drug 4 weeks or 5 half lives, whichever was longer, prior to the first dose of study drug
- A positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab
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 |
|---|---|---|
| Pegylated interferon and ribavirinAlso: Pegasys and CopegusPegylated interferon 180 ug subcutaneous per week Ribavirin 1000-1200 mg /day for genotype 1 and 800 mg /day orally for genotype non 1 Duration: 48 weeks for genotype 1 and 24 weeks for gentoype non 1 | Drug | pegylated interferon and ribavirin |
| Pegylated interferon and ribavirinAlso: Pegasys and CopegusPegylated interferon 180 ug/ week subcutaneously Ribavrin 1000-1200 mg /day for genotype 1 and 800 mg/day orally for genotype 2 and 3 Treatment duration 48 weeks for genotype 1 and 24 weeks for genotypes 2 and 3 | Drug | pegylated interferon and ribavirin |
Primary outcome
Sustained virological response
Time frame: 24 weeks post cessation of HCV therapy
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 30 Jan 2024.
- Derived from this study: PubMed 21205057Sasadeusz JJ, Dore G, Kronborg I, Barton D, Yoshihara M, Weltman M. Clinical experience with the treatment of hepatitis C infection in patients on opioid pharmacotherapy. Addiction. 2011 May;106(5):977-84. doi: 10.1111/j.1360-0443.2010.03347.x.
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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.
Joseph J Sasadeusz, MBBS principal investigator
Melbourne Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegylated interferon and ribavirin in people with Chronic Hepatitis C, run by Melbourne Health at 4 sites in Australia.
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 9 inclusion and 14 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. 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?
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.
What does the primary outcome measure?
Sustained virological response (time frame: 24 weeks post cessation of HCV therapy). 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 NCT01120795, which also lists 1 linked publication.
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 30 Jan 2024.