Hepatitis CPhase 3NCT00527540
Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C
A Phase 3 study testing Pegylated Interferon alpha 2a + Ribavirin in people with Hepatitis C, run by Tehran Hepatitis Center at 1 site in Iran.
Trial summary
Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a (Pegaferon®) in the patients with chronic hepatitis C. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Pegylated Interferon alpha 2a + Ribavirin
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Feb 2007to Dec 2008
- Phase
- Phase 3
- 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
- HCV RNA: Positive
- Biopsy approved in genotype 1
- Age older than 18 yrs
Who cannot join
- ongoing pregnancy or breast feeding
- Hx of hemochromatosis
- Hx of metabolic liver dis.
- Hx of HCC
- Hx of autoimmune hepatitis
- Hx of alcoholic liver dis.
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- Hx of bleeding from esophageal varices
- ongoing systemic anti-viral or anti-neoplasmic treatment
- Hx of treatment with an anti-depressant medication at therapeutic doses for at least 3 months at any pervious time
- Hx of treatment with an tranquilizer at therapeutic doses for psychosis for at least 3 months at any pervious time
- Hx of hospitalization for psychiatric dis.
- Hx of suicidal attempt
- Hx of IBD
- Hx of SLE
- Hx of scleroderma
- Hx of rheumatoid arthritis
- Hx of ITP
- Hx of autoimmune hemolytic anemia
- Hx of severe psoriasis
- Hx of chronic pulmonary dis. associated with functional limitation
- Hx of MI or unstable angina
- Hx of arrhythmia requiring ongoing treatment
- Hx of functional class III or IV
- Hx of severe seizure dis. or current anti-convulsant use
- Hx of organ transplantation with existing functional graft
- Hx of severe retinopathy
- Hx of Thalassemia
- Hx of spherocytosis
- Hx of cerebrovascular dis.
Trial locations and contacts
1 site in 1 country.
About this study
Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a (Pegaferon®) in the patients with chronic hepatitis C.
Read the detailed description
We enroll 50 patients in to the study. The patients receive Pegaferon® 180 micgr per week plus ribavirin 10-15mg/kg per day. The patients are visited every 4 weeks with biochemistry lab tests. They are checked with quantitative HCV PCR on the third month 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
- Being tested
- Pegylated Interferon alpha 2a + Ribavirin
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Interferon alpha 2a + RibavirinDrug
Also called Pegaferon
Pegaferon: Ampule, 180 microgram per week Ribaverin: Tablet, 10-15 mg/kg per day
What is being measured
The primary outcome is the main question the study is designed to answer.
End of treatment response rate (HCV RNA:Neg)
Measured: End of treatment course
Secondary outcomes (1)
Sustain response rate (HCV RNA:Neg) 6 month after end of treatment
Measured: 6 month after 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 posted11 Sep 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran Hepatitis Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kermanshah University of Medical Sciences
- Investigators
- Seyed M Alavian, Prof., Study chair, Tehran Hepatitis CenterBehzad Hajarizadeh, MD, Principal investigator, Tehran Hepatitis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527540
- Sponsor's protocol ID
- THC-10
- Status last verified
- Jan 2009
- First submitted
- 8 Sep 2007
- Last updated
- 21 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00527540
- Acronym / sponsor ID
- THC-10
- Conditions
- Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tehran Hepatitis CenterUniversity, hospital or other
- Collaborators
- Kermanshah University of Medical Sciences
- Study start
- Feb 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Sep 2007 (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.
Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a (Pegaferon®) in the patients with chronic hepatitis C.
Detailed description
We enroll 50 patients in to the study. The patients receive Pegaferon® 180 micgr per week plus ribavirin 10-15mg/kg per day. The patients are visited every 4 weeks with biochemistry lab tests. They are checked with quantitative HCV PCR on the third month 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HCV RNA: Positive
- Biopsy approved in genotype 1
- Age older than 18 yrs
Key exclusion criteria (29 listed)
- ongoing pregnancy or breast feeding
- Hx of hemochromatosis
- Hx of metabolic liver dis.
- Hx of HCC
- Hx of autoimmune hepatitis
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 alpha 2a + RibavirinAlso: PegaferonPegaferon: Ampule, 180 microgram per week Ribaverin: Tablet, 10-15 mg/kg per day | Drug | – |
Primary outcome
End of treatment response rate (HCV RNA:Neg)
Time frame: End of treatment course
1 secondary outcome
Sustain response rate (HCV RNA:Neg) 6 month after end of treatment
Time frame: 6 month after 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 21 Jan 2009.
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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 M Alavian, Prof. study chair
Tehran Hepatitis Center
Behzad Hajarizadeh, MD principal investigator
Tehran Hepatitis Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegylated Interferon alpha 2a + Ribavirin in people with Hepatitis C, run by Tehran Hepatitis Center 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 3 inclusion and 29 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 21 Jan 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
End of treatment response rate (HCV RNA:Neg) (time frame: End of treatment course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2009.