Hepatitis CPhase 4NCT00707850
Pegasys® Plus Ribavirin in Thalassemic Patients With Hepatitis C Virus Infection
A Phase 4 study testing PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in people with Hepatitis C and Thalassemia, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
Trial summary
Antiviral treatment of HCV in thalassemia has raised concerns of ribavirin-induced hemolysis and increased iron loading. Blood Transfusion in Thalassemic patients are a known high risk for acquiring hepatitis C. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hepatitis C, Thalassemia
- What is being tested?
- PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIran
- Study dates
- May 2007to Sep 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HCV RNA positive
- Age older than 12 years
Who cannot join
- Ongoing pregnancy or breast feeding
- History (Hx) of Hepatocellular Carcinoma (HCC)
- Hx of alcoholic liver disease
- Hx of bleeding from esophageal varices
- Hx of hemochromatosis
- Hx of autoimmune hepatitis
Show all 13Show fewer
- Hx of Suicidal attempt
- Hx of cerebrovascular dis
- Hx of severe retinopathy
- Hx of severe psoriasis
- Hx of scleroderma
- Hx of metabolic liver disease
- Hx of Systemic Lupus Erythematosus (SLE)
Trial locations and contacts
1 site in 1 country.
Iran1 site
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran, Tehran Province, 14155-3651
About this study
Official title: A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Thalassemic Patients With Chronic Hepatitis C Infection
Antiviral treatment of HCV in thalassemia has raised concerns of ribavirin-induced hemolysis and increased iron loading. Blood Transfusion in Thalassemic patients are a known high risk for acquiring hepatitis C. The investigators are trying the PEGASYS (Peginterferon alpha-2a(40 KD)) plus Ribavirin in Thalassemic patients with HCV.
Read the detailed description
Patients with Thalassemia receive chronic blood transfusions and have an increased prevalence of chronic Hepatitis C virus (HCV) infection, particularly if transfused before HCV serological testing became available. The investigators enrolled 300 patients into the study. The patients received PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 1000 milligram for weight less than or equal 75 kg and 1200 milligram for more than 75 kg for 48 weeks. Follow up period is 6 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the third months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.
- Conditions
- Hepatitis C, Thalassemia
- Being tested
- PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
- Keywords
- Hepatitis C, Thalassemia, Pegasys, Ribavirin
- Medical subject headings
- Hepatitis C, Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)Drug
Also called Peginterferon Alfa-2a (40KD) plus COPEGUS
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: [=<75 kg: 1000 mg; >75 kg: 1200 mg per day (PO)]
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Thalassemic Patients with HCV Receives: Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Virologic Response
Measured: After 12 weeks of Treatment
End of Treatment Response
Measured: 48 Weeks
Sustained Virologic Response
Measured: 24 weeks after Treatment
Rapid Virologic Response
Measured: One month after Treatment
Secondary outcomes (3)
Tolerability of drugs for whole therapy period
Measured: During Treatment
Biochemical response (ALT)
Measured: End of Treatment AND 24 weeks after Treatment
Laboratory Parameters
Measured: During Treatment AND End of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startMay 2007
- Primary completionSep 2009
- Study completionSep 2009
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 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Tehran Hepatitis Center, Guilan University of Medical Sciences, Tabriz Research Center for Gastroenterology and Liver Diseases
- Investigators
- Seyed-Moayed Alavian, Professor, Study chair, Baqiyatallah Research Center for Gastroenterology and Liver DiseaSeyyed Mohammad Miri, M.D., Study director, Baqiyatallah Research Center for Gastroenterology and Liver DiseaPegah Karimi, M.D., Principal investigator, Baqiyatallah Research Center for Gastroenterology and Liver DiseasesMaryam Keshvari, M.D., Principal investigator, Iranian blood Transfusion Research CenterBita Behnava, M.D., Principal investigator, Baqiyatallah Research Center for Gastroenterology and Liver DiseasesMohammad Hossein Somi, M.D., Principal investigator, Research Center for Gastroenterology and Hepatology, Tabriz University of Medical Sciences, TabrizFariborz Mansour-Ghanaei, M.D., Principal investigator, Gastroenterology and Liver Diseases, Gastrointestinal and Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707850
- Sponsor's protocol ID
- BRCGL-08-06
- Status last verified
- Sep 2009
- First submitted
- 26 Jun 2008
- Last updated
- 31 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harmatz P, Jonas MM, Kwiatkowski JL, Wright EC, Fischer R, Vichinsky E, Giardina PJ, Neufeld EJ, Porter J, Olivieri N; Thalassemia Clinical Research Network. Safety and efficacy of pegylated interferon alpha-2a and ribavirin for the treatment of hepatitis C in patients with thalassemia. Haematologica. 2008 Aug;93(8):1247-51. doi: 10.3324/haematol.12352. Epub 2008 Jun 12.
PubMed 18556414
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Thalassemic Patients With Chronic Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT00707850
- Acronym / sponsor ID
- BRCGL-08-06
- Conditions
- Hepatitis C, Thalassemia
- Keywords
- Hepatitis C, Thalassemia, Pegasys, Ribavirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Collaborators
- Baqiyatallah Research Center for Gastroenterology and Liver Diseases, Tehran Hepatitis Center, Guilan University of Medical Sciences, Tabriz Research Center for Gastroenterology and Liver Diseases
- Study start
- May 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 1 Jul 2008 (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.
Antiviral treatment of HCV in thalassemia has raised concerns of ribavirin-induced hemolysis and increased iron loading. Blood Transfusion in Thalassemic patients are a known high risk for acquiring hepatitis C. The investigators are trying the PEGASYS (Peginterferon alpha-2a(40 KD)) plus Ribavirin in Thalassemic patients with HCV.
Detailed description
Patients with Thalassemia receive chronic blood transfusions and have an increased prevalence of chronic Hepatitis C virus (HCV) infection, particularly if transfused before HCV serological testing became available. The investigators enrolled 300 patients into the study. The patients received PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 1000 milligram for weight less than or equal 75 kg and 1200 milligram for more than 75 kg for 48 weeks. Follow up period is 6 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the third months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)Thalassemic Patients with HCV |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- HCV RNA positive
- Age older than 12 years
Key exclusion criteria (13 listed)
- Ongoing pregnancy or breast feeding
- History (Hx) of Hepatocellular Carcinoma (HCC)
- Hx of alcoholic liver disease
- Hx of bleeding from esophageal varices
- Hx of hemochromatosis
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 |
|---|---|---|
| PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)Also: Peginterferon Alfa-2a (40KD) plus COPEGUSPEGASYS: 180 microgram per week (Injection) Plus Ribavirin: [=<75 kg: 1000 mg; >75 kg: 1200 mg per day (PO)] | Drug | 1 |
Primary outcome
Early Virologic Response
Time frame: After 12 weeks of Treatment
End of Treatment Response
Time frame: 48 Weeks
Sustained Virologic Response
Time frame: 24 weeks after Treatment
Rapid Virologic Response
Time frame: One month after Treatment
3 secondary outcomes
Tolerability of drugs for whole therapy period
Time frame: During Treatment
Biochemical response (ALT)
Time frame: End of Treatment AND 24 weeks after Treatment
Laboratory Parameters
Time frame: During Treatment AND End 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 31 Aug 2010.
- Background: PubMed 18556414Harmatz P, Jonas MM, Kwiatkowski JL, Wright EC, Fischer R, Vichinsky E, Giardina PJ, Neufeld EJ, Porter J, Olivieri N; Thalassemia Clinical Research Network. Safety and efficacy of pegylated interferon alpha-2a and ribavirin for the treatment of hepatitis C in patients with thalassemia. Haematologica. 2008 Aug;93(8):1247-51. doi: 10.3324/haematol.12352. Epub 2008 Jun 12.
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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.
Seyed-Moayed Alavian, Professor study chair
Baqiyatallah Research Center for Gastroenterology and Liver Disea
Seyyed Mohammad Miri, M.D. study director
Baqiyatallah Research Center for Gastroenterology and Liver Disea
Pegah Karimi, M.D. principal investigator
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
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 PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in people with Hepatitis C and Thalassemia, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
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 2 inclusion and 13 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 31 Aug 2010. 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 Iran. 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?
Early Virologic Response (time frame: After 12 weeks of Treatment). The study lists 4 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 NCT00707850, 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 31 Aug 2010.