Chronic Hepatitis CPhase 4PEGPRINCT00209898
Hepatitis C Treatment of Inmates
A Phase 4 study testing Fast initiation procedure in people with Chronic Hepatitis C, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Hepatitis C infection is a prevalent chronic disease. It is particularly prevalent among intravenous drug abusers. Bergen fengsel is a regional prison housing 250 inmates, of which as many as 70 are recorded HCV RNA PCR positive annuallly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Fast initiation procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2003to Jan 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serologic evidence of chronic hepatitis C infection by an anti-HCV test
- Serum HCV-RNA quantifiable at > 600 IU/mL or 1000 copies/mL by the Roche AMPLICOR HCV MONITOR Test, v2.0
- Patients with both normal or elevated serum ALT are eligible
- Compensated liver disease (Child-Pugh grade A clinical classification)
- Patients with cirrhosis or transition to cirrhosis must have an abdominal ultrasonography, CT scan or MRI scan without evidence of hepatocellular carcinoma and a serum AFP < 100 ng/mL within 2 months of randomization
- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24 hour period prior to first dose of study drug
- All fertile males and females receiving RBV must be using two forms of effective contraception during treatment and during the 6 months after treatment ends
Who cannot join
- Women with ongoing pregnancy or breat feeding
- Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic soses of steroids and radiation) < 6 months prior to the first dose of study drug
- Any investigational drug < 6 weeks prior to the first dose of study drug Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBsAg, anti-HBc Ab, anti-HIV Ab.
- History or evidence of a medical condition associated with chronic liver disease other than HCV (e.g. hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- History or evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- Neutrophil count < 1500/mm or platelet count < 90,000 cells/mm at screening
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- Serum creatinine level > 1,5 times the ULN at screening
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or neuroleptica at therapeutic doses for major depression or psychosis, respectively for at least 3 months at any previous time, or any history of the following; a suicidal attempt, hospitalization for psychiatric disease or a period of disability due to psychiatric disease
- History of severe seizure disorder or current anticonvulsant disease
- History of immunologically mediated disease (e.g. IBD, ITP, LED, AIHA, scleroderma, severe psoriasis or RA etc.)
- History or other evidence of chronic pulmonary disease associated with functional limitation
- History of major organ transplantation with an existing functional graft
- History of severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months of ventricular arrhythmias requiring ongoing treatment, unstable angina or other significant CVD)
- History or other evidence of severe illness, malignancy or other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
- Evidence of ongoing drug abuse (including excessive alcohol consumption)
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- Male partners of women who are pregnant
- Hemoglobin < 12 g/dL in women or < 13g/dL in men at screening
- Any patient with an increased baseline risk for anemia or for whom anemia would be medically problematic
- Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgement of the investigator, an acuter decrease in hemoglobin by up to 4 g/dL would not be well-tolerated
Trial locations and contacts
1 site in 1 country.
Norway1 site
Unit for infectious diseases outpatient clincic, Dept. Internal Medicine
Bergen, Bergen, N-5021
About this study
Official title: Hepatitis C Treatment of Inmates. A Randomized, Open-label Study Evaluating the Feasibility, Safety and Efficacy of Treatment With Peginterferon Alfa-2a in Combination With Ribavirin in Inmate Patients With Chronic Hepatitis C
Hepatitis C infection is a prevalent chronic disease. It is particularly prevalent among intravenous drug abusers. Bergen fengsel is a regional prison housing 250 inmates, of which as many as 70 are recorded HCV RNA PCR positive annuallly. In this study inmate males and females will be randomized to standard screening and initiation procedure, or to a rapid initiation procedure in the hospital's infectious diseases outpatient clinic. The study aims at studying if rapid inclusion will increase the possibility to conclude treatment while the prisoner still is incarcerated, thus improve the chances of reaching a sustained virologic response, compared to standard inclusion, where prisoners, as other out patients will wait for inclusion for several months.
- Conditions
- Chronic Hepatitis C
- Being tested
- Fast initiation procedure
- Keywords
- Chronic hepatits C, peginterferon, ribavirin, inmate, fast initiation procedure
- 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.
Fast initiation procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Rapid standard of care | Active comparator | Rapid standard of care treatment after screening Receives: Procedure: Fast initiation procedure |
| Ordinary standard of care | Active comparator | Subject put on ordinary waiting list for hcv treatment in Our outpatient clinic Receives: Procedure: Fast initiation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
- adherence
- Sustained virologic response rates defined as percentage of patients with non-detectable HCV-RNA as measured by Roche AMPLICOR HCV Test, v2.0 (>50 IU/mL).
Secondary outcomes (5)
Percentage of patients with non-detectable HCV-RNA at study week 12, 24 and 48 as measured by Roche AMPLICOR HCV Test v2.0 (<50 IU/mL).
- adverse event rate and profile
- Hemoglobin
- Other laboratory tests
- Medical Outcomes Study 36 Item Short Form health Survey (SF-36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Low inclusion rate
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.
- More trials run by Haukeland University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bergen Prison, Norwegian Correctional Service, Hoffmann-La Roche
- Responsible party
- Principal investigator, Steinar Skrede, Haukeland University Hospital
- Investigators
- Steinar Skrede, M.D., Ph.D., Principal investigator, Unit for infectious diseases, Dept. Internal Medicine, Haukeland UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209898
- Sponsor's protocol ID
- 12952
- Acronym
- PEGPRI
- Status last verified
- Jun 2003
- First submitted
- 13 Sep 2005
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
-Dalgard,O., Jeansson, S., Skaug, K, Raknerud, N., Bell, H. Hepatitis C in the general adult population of Oslo; prevalence and clinical spectrum. Scand. J. Gastroenterol. 38:864-870, 2003. -Stein, M.D., Maksad, J., Clarke, J. Hepatitis C among injecting drug users: knowledge, perceived risk and willingness to receive treatment. Drug Alc. Depend. 61:211-215, 2001. -Allen,S.A., Spaulding,A.C., Osei,A.M., Taylor,L.E., Cabral,A.M. and Rich,J.D. Treatment of chronic hepatitis C in a state correctional facility. Ann. Intern. Med. 138:187-190, 2003. -Dalgard,O., Bjøro,K., Hellum,K., Skaug,K., Gutigard,B.,Bell, H. Treatment of chronic hepatitis C in injecting drug users: 5 years' folow up. Eur. Addict. Res. 8:45-49, 2002.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Treatment of Inmates. A Randomized, Open-label Study Evaluating the Feasibility, Safety and Efficacy of Treatment With Peginterferon Alfa-2a in Combination With Ribavirin in Inmate Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00209898
- Acronym / sponsor ID
- PEGPRI / 12952
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatits C, peginterferon, ribavirin, inmate, fast initiation procedure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low inclusion rate
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Bergen Prison, Norwegian Correctional Service, Hoffmann-La Roche
- Study start
- Aug 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 21 Sep 2005 (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.
Hepatitis C infection is a prevalent chronic disease. It is particularly prevalent among intravenous drug abusers. Bergen fengsel is a regional prison housing 250 inmates, of which as many as 70 are recorded HCV RNA PCR positive annuallly. In this study inmate males and females will be randomized to standard screening and initiation procedure, or to a rapid initiation procedure in the hospital's infectious diseases outpatient clinic. The study aims at studying if rapid inclusion will increase the possibility to conclude treatment while the prisoner still is incarcerated, thus improve the chances of reaching a sustained virologic response, compared to standard inclusion, where prisoners, as other out patients will wait for inclusion for several months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid standard of care | Active comparator | Procedure: Fast initiation procedureRapid standard of care treatment after screening |
| Ordinary standard of care | Active comparator | Procedure: Fast initiation procedureSubject put on ordinary waiting list for hcv treatment in Our outpatient clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Serologic evidence of chronic hepatitis C infection by an anti-HCV test
- Serum HCV-RNA quantifiable at > 600 IU/mL or 1000 copies/mL by the Roche AMPLICOR HCV MONITOR Test, v2.0
- Patients with both normal or elevated serum ALT are eligible
- Compensated liver disease (Child-Pugh grade A clinical classification)
- Patients with cirrhosis or transition to cirrhosis must have an abdominal ultrasonography, CT scan or MRI scan without evidence of hepatocellular carcinoma and a serum AFP < 100 ng/mL within 2 months of randomization
Key exclusion criteria (21 listed)
- Women with ongoing pregnancy or breat feeding
- Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic soses of steroids and radiation) < 6 months prior to the first dose of study drug
- Any investigational drug < 6 weeks prior to the first dose of study drug Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBsAg, anti-HBc Ab, anti-HIV Ab.
- History or evidence of a medical condition associated with chronic liver disease other than HCV (e.g. hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- History or evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
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 |
|---|---|---|
| Fast initiation procedure | Procedure or surgery | Ordinary standard of care, Rapid standard of care |
Primary outcome
- adherence
- Sustained virologic response rates defined as percentage of patients with non-detectable HCV-RNA as measured by Roche AMPLICOR HCV Test, v2.0 (>50 IU/mL).
5 secondary outcomes
Percentage of patients with non-detectable HCV-RNA at study week 12, 24 and 48 as measured by Roche AMPLICOR HCV Test v2.0 (<50 IU/mL).
- adverse event rate and profile
- Hemoglobin
- Other laboratory tests
- Medical Outcomes Study 36 Item Short Form health Survey (SF-36)
Results and safety
The study was stopped early (reason given: Low inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
- Background-Dalgard,O., Jeansson, S., Skaug, K, Raknerud, N., Bell, H. Hepatitis C in the general adult population of Oslo; prevalence and clinical spectrum. Scand. J. Gastroenterol. 38:864-870, 2003. -Stein, M.D., Maksad, J., Clarke, J. Hepatitis C among injecting drug users: knowledge, perceived risk and willingness to receive treatment. Drug Alc. Depend. 61:211-215, 2001. -Allen,S.A., Spaulding,A.C., Osei,A.M., Taylor,L.E., Cabral,A.M. and Rich,J.D. Treatment of chronic hepatitis C in a state correctional facility. Ann. Intern. Med. 138:187-190, 2003. -Dalgard,O., Bjøro,K., Hellum,K., Skaug,K., Gutigard,B.,Bell, H. Treatment of chronic hepatitis C in injecting drug users: 5 years' folow up. Eur. Addict. Res. 8:45-49, 2002.
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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.
Steinar Skrede, M.D., Ph.D. principal investigator
Unit for infectious diseases, Dept. Internal Medicine, Haukeland UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fast initiation procedure in people with Chronic Hepatitis C, run by Haukeland University Hospital at 1 site in Norway.
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 7 inclusion and 21 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: stopped early, as of the sponsor's last update on 20 Mar 2015. 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 Norway. 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 was stopped early (reason given: Low inclusion rate). Results are not available in the source record.
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?
- adherence. The study lists 2 primary outcomes in all. 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 NCT00209898, 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 20 Mar 2015.