Chronic Hepatitis CPhase 4NCT00881582
Peginterferon Alfa-2a Plus Ribavirin Combination Treatment in Chronic Hepatitis C Post-Renal Transplant Patients
A Phase 4 study testing Pegylated interferon alfa-2a plus ribavarin in people with Chronic Hepatitis C and Renal Transplant, run by King Abdulaziz Medical City at 2 sites in Saudi Arabia.
Trial summary
There is a distinct lack of published literature on the effect of combination treatment of PEG-interferon and ribavirin on post-renal transplantation hepatitis C virus (HCV) patients. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Chronic Hepatitis C, Renal Transplant
- What is being tested?
- Pegylated interferon alfa-2a plus ribavarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- Jan 2009to Dec 2011
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, male and female, aged 18 - 68 years
- Post renal transplant patients exceeding one year
- Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months AND/OR
- Detectable serum quantitative HCV-RNA (Cobas Amplicor HCV Monitor v2.0, Roche Molecular Systems, Pleasanton, CA) with lower limit of detection at 50 IU/mL
- Compensated liver disease with the following minimum hematologic and biochemical criteria:
- Hemoglobin > 10 g/dL
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- WBC > 3000/mm3 ; granulocyte count > 1,500/mm3
- Platelet count > 75,000/mm3
- Albumin within normal limits
- TFT within normal limits
- ANA < 1:320
- Ultrasound of the liver obtained within the preceding 6 months of study entry
- Liver biopsy prior to entry confirming a histological diagnosis consistent with HCV necroinflammatory score (METAVIR) > 1, and fibrosis score >/= 2.
Who cannot join
- Previous treatment with interferon and / or Ribavirin - based therapy for chronic hepatitis C
- Co-infection with HBV or HIV
- Chronic alcohol abuse (daily consumption > 20 g/day)
- Autoimmune or metabolic liver disease liver disease
- Active drug-induced hepatitis or HAV
- Decompensated liver disease (Child-Pugh classification B or C) including a past history of decompensation
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- Variceal bleeding
- Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder due to diabetes mellitis or hypertension
- Neoplastic disease
- Patients with a value of alpha-fetoprotein >100 ng/mL will be excluded from the study until imaging studies confirm the absence of HCC. Presence of HCC, as determined by other means will also exclude the patient from histological sampling.
- Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (40 g/L) (as may be seen with ribavirin therapy) would not be well-tolerated
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer 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 a psychiatric disease
- Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
- Current pregnancy, ongoing breast feeding or unwilling to have contraception
- Bleeding or clotting diatheses
- Recent history of renal allograft rejection (< 6 months)
- Inability or unwillingness to provide informed consent or abide by the requirements of the study.
- History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
- History of organ transplantation, other than kidney, with an existing functional graft.
- Patients requiring dialysis or in whom dialysis is impending.
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
King Faisal Specialist Hospital & Research Centre
Riyadh, 11159
Riyadh Military Hospital
Riyadh, 11159
About this study
There is a distinct lack of published literature on the effect of combination treatment of PEG-interferon and ribavirin on post-renal transplantation hepatitis C virus (HCV) patients. Small case series have been published utilizing conventional interferon and/or ribavirin and the available data is extremely preliminary in nature. A small retrospective series of patients treated with Pegylated interferon and ribavirin published recently suggests that the treatment may be safe and efficacious. Unpublished reports from a few centers within Saudi Arabia also suggest a good safety profile and reasonable efficacy from this form of combination treatment.
The investigators aim to prospectively study the safety and efficacy of PEG-interferon and ribavirin combination therapy in post-renal transplant HCV-infected patients. Towards this 40 patients with histological evidence of liver disease will be recruited and the efficacy of the above medications studied.
The proposed study aims to evaluate the efficacy and safety of PEG-interferon and ribavirin combination therapy in the treatment of chronic HCV in renal transplant patients in a way that will allow management of such patients in an optimized manner.
- Conditions
- Chronic Hepatitis C, Renal Transplant
- Being tested
- Pegylated interferon alfa-2a plus ribavarin
- Keywords
- Hepatitis c, Renal transplantation, Pegylated interferon
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated interferon alfa-2a plus ribavarinDrug
Also called Pegasys®, F. Hoffman-LaRoche, Copegus®, F. Hoffman-LaRoche
PEG-interferon alfa-2a and ribavirin. Pegylated interferon alfa-2a - standard dose; plus ribavirin - standard dose (determined by creatinine clearance); for 24 to 48 weeks (genotypes 1 \& 4: 48 weeks; genotypes 2 \& 3: 24 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Pegylated interferon alfa-2a plus ribavarin | Experimental | Pegylated interferon alfa-2a plus ribavarin for 48 weeks Receives: Drug: Pegylated interferon alfa-2a plus ribavarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response
Measured: At 24 weeks post completion of treatment
Secondary outcomes (1)
Adverse event rate and number of cases of graft rejection
Measured: Assessment at 4, 12, 24 and 48 weeks on treatment, and 24 weeks post completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz Medical City
- Sponsor type
- Other government
- Collaborators
- Riyadh Military Hospital, King Faisal Specialist Hospital & Research Center
- Responsible party
- Principal investigator, Faisal M Sanai, King Abdulaziz Medical City
- Investigators
- Faisal M Sanai, MBBS, MD, Principal investigator, Riyadh Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881582
- Sponsor's protocol ID
- RMH-01-09
- Status last verified
- Sep 2012
- First submitted
- 14 Apr 2009
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sanai FM, Mousa D, Al-Mdani A, Al-Shoail G, Al-Ashgar H, Al Meshari K, Al-Qahtani A, Saadeh M, Bzeizi KI, Aleid H. Safety and efficacy of peginterferon-alpha2a plus ribavirin treatment in renal transplant recipients with chronic hepatitis C. J Hepatol. 2013 Jun;58(6):1096-103. doi: 10.1016/j.jhep.2013.02.004. Epub 2013 Feb 18.
PubMed 23428875
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peginterferon Alfa-2a Plus Ribavirin Combination Treatment in Chronic Hepatitis C Post-Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT00881582
- Acronym / sponsor ID
- RMH-01-09
- Conditions
- Chronic Hepatitis C, Renal Transplant
- Keywords
- Hepatitis c, Renal transplantation, Pegylated interferon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- King Abdulaziz Medical CityOther government
- Collaborators
- Riyadh Military Hospital, King Faisal Specialist Hospital & Research Center
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Apr 2009 (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.
There is a distinct lack of published literature on the effect of combination treatment of PEG-interferon and ribavirin on post-renal transplantation hepatitis C virus (HCV) patients. Small case series have been published utilizing conventional interferon and/or ribavirin and the available data is extremely preliminary in nature. A small retrospective series of patients treated with Pegylated interferon and ribavirin published recently suggests that the treatment may be safe and efficacious. Unpublished reports from a few centers within Saudi Arabia also suggest a good safety profile and reasonable efficacy from this form of combination treatment.
The investigators aim to prospectively study the safety and efficacy of PEG-interferon and ribavirin combination therapy in post-renal transplant HCV-infected patients. Towards this 40 patients with histological evidence of liver disease will be recruited and the efficacy of the above medications studied.
The proposed study aims to evaluate the efficacy and safety of PEG-interferon and ribavirin combination therapy in the treatment of chronic HCV in renal transplant patients in a way that will allow management of such patients in an optimized manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegylated interferon alfa-2a plus ribavarin | Experimental | Drug: Pegylated interferon alfa-2a plus ribavarinPegylated interferon alfa-2a plus ribavarin for 48 weeks |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients, male and female, aged 18 - 68 years
- Post renal transplant patients exceeding one year
- Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months AND/OR
- Detectable serum quantitative HCV-RNA (Cobas Amplicor HCV Monitor v2.0, Roche Molecular Systems, Pleasanton, CA) with lower limit of detection at 50 IU/mL
- Compensated liver disease with the following minimum hematologic and biochemical criteria:
Key exclusion criteria (20 listed)
- Previous treatment with interferon and / or Ribavirin - based therapy for chronic hepatitis C
- Co-infection with HBV or HIV
- Chronic alcohol abuse (daily consumption > 20 g/day)
- Autoimmune or metabolic liver disease liver disease
- Active drug-induced hepatitis or HAV
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 alfa-2a plus ribavarinAlso: Pegasys®, F. Hoffman-LaRoche, Copegus®, F. Hoffman-LaRochePEG-interferon alfa-2a and ribavirin. Pegylated interferon alfa-2a - standard dose; plus ribavirin - standard dose (determined by creatinine clearance); for 24 to 48 weeks (genotypes 1 \& 4: 48 weeks; genotypes 2 \& 3: 24 weeks) | Drug | Pegylated interferon alfa-2a plus ribavarin |
Primary outcome
Sustained Virologic Response
Time frame: At 24 weeks post completion of treatment
1 secondary outcome
Adverse event rate and number of cases of graft rejection
Time frame: Assessment at 4, 12, 24 and 48 weeks on treatment, and 24 weeks post completion of treatment
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 14 Sep 2012.
- Derived from this study: PubMed 23428875Sanai FM, Mousa D, Al-Mdani A, Al-Shoail G, Al-Ashgar H, Al Meshari K, Al-Qahtani A, Saadeh M, Bzeizi KI, Aleid H. Safety and efficacy of peginterferon-alpha2a plus ribavirin treatment in renal transplant recipients with chronic hepatitis C. J Hepatol. 2013 Jun;58(6):1096-103. doi: 10.1016/j.jhep.2013.02.004. Epub 2013 Feb 18.
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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.
Faisal M Sanai, MBBS, MD principal investigator
Riyadh Military Hospital
2 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 alfa-2a plus ribavarin in people with Chronic Hepatitis C and Renal Transplant, run by King Abdulaziz Medical City at 2 sites in Saudi Arabia.
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 13 inclusion and 20 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 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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 Virologic Response (time frame: At 24 weeks post completion of treatment). 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 NCT00881582, 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 14 Sep 2012.