Hepatitis CPhase 4NCT00707772

Pegasys® Plus Ribavirin in Hemophilic 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 Hemophilia, run by Baqiyatallah Medical Sciences University at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Hemophilic patients are a known high risk groups for acquiring the hepatitis C. The surveillance data from Ministry Of Health in IR.Iran had shown that 60% of them are infected with HCV infection. We are trying the PEGASYS plus Ribavirin in Hemophilic patients with HCV. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Hepatitis C, Hemophilia
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: 400 participants
Where: 1 siteIran
Study dates: Mar 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
Hx of 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 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

Other trials in Iran

About this study

Official title: A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Hemophilic Patients With Chronic Hepatitis C Infection

Read the detailed description

The investigators enroll 400 patients into the study. The patients receive PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 800 microgram for Genotype 2 and 3 and 1000 milligram for weight less than 75 kg and 1200 milligram for more than 75 kg. The duration of protocol is depends on genotypes of virus. In genotype 1 and 4, for 48 week and in genotypes 2 and 3 , for 24 weeks. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA 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. We have omitted the liver biopsy in the patients.

Conditions: Hepatitis C, Hemophilia
Being tested: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
Keywords: Hepatitis C, Hemophilia, Pegasys, Ribavirin
Medical subject headings: Hepatitis C, Hemophilia A

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: 800 milligram per day (PO)
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 groups in NCT00707772
Study group	Role	What they receive
1	Active comparator	Genotype 2 or 3 in Hemophilic Patients with HCV Receives: Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
2	Active comparator	Other Genotypes (except 2 or 3) in Hemophilic 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: 24 weeks for : Genotype 2 & 3; 48 Weeks for other genotype
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.

Mar 2007Sep 2009

First posted1 Jul 2008 (estimated)
Study startMar 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: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00707772
Sponsor's protocol ID: BRCGL-07-03
Other IDs: BRCGL-07-03
Status last verified: Sep 2009
First submitted: 26 Jun 2008
Last updated: 17 Sep 2009
Results posted: No
Data monitoring committee: Yes

Publications

Iafolla M. [Pegasys: FDA approved Pegasys (peginterferon alfa-2a) for the treatment of hepatitis C]. Sidahora. 2002;(4):8-10. No abstract available. Spanish.
PubMed 12703472

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2009. 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 Hemophilic Patients With Chronic Hepatitis C Infection
ClinicalTrials.gov ID: NCT00707772
Acronym / sponsor ID: BRCGL-07-03
Conditions: Hepatitis C, Hemophilia
Keywords: Hepatitis C, Hemophilia, Pegasys, Ribavirin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 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, Shahid Beheshti University of Medical Sciences, Iran University of Medical Sciences
Study start: Mar 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)Genotype 2 or 3 in Hemophilic Patients with HCV
2	Active comparator	Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)Other Genotypes (except 2 or 3) in Hemophilic 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
Hx of 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: 800 milligram per day (PO)	Drug	1
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	2

Primary outcome

Early Virologic Response
Time frame: After 12 weeks of Treatment
End of Treatment Response
Time frame: 24 weeks for : Genotype 2 & 3; 48 Weeks for other genotype
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 17 Sep 2009.
Background: PubMed 12703472Iafolla M. [Pegasys: FDA approved Pegasys (peginterferon alfa-2a) for the treatment of hepatitis C]. Sidahora. 2002;(4):8-10. No abstract available. Spanish.

Related trials for Hepatitis C

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
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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.

Professor Seyed-Moayed Alavian, Professor study chair

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Seyyed Mohammad Miri, M.D. study director

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

Maryam Keshvari, M.D. principal investigator

Iranian blood Transfusion Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 17 Sep 2009. 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 NCT00707772, 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 17 Sep 2009.