Hepatitis CPhase 3NCT01137383
Pegaferon and Ribavirin for Hepatitis C
A Phase 3 study testing Pegaferon (pegylated interferon alpha 2a) + ribavirin in people with Hepatitis C, run by Tehran University of Medical Sciences at 2 sites in Iran.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be treated using standard guidelines for hepatitis C. Response to treatment and side effects will be recorded. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Pegaferon (pegylated interferon alpha 2a) + ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesIran
- Study dates
- Dec 2007to Feb 2010
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic hepatitis C
- Age between 15 and 65
Who cannot join
- previous treatment for chronic hepatitis C
- co-infection with human immunodeficiency virus or hepatitis B virus
- major thalassemia or hemophilia
- active drug user
- being treated for major depression or psychosis
- decompensated cirrhosis
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- serum creatinine > 1.5 mg/dL
- solid organ transplant
- untreated thyroid disease
- uncontrolled diabetes mellitus
- uncontrolled autoimmune disease
- advanced cardiac or pulmonary disease.
- planning to become pregnant in the next 1.5 years
- patients with inadequate contraception
- not consenting to the study
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Safety and Efficacy of Locally Manufactured Pegylated Interferon in Hepatitis C Patients
The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be treated using standard guidelines for hepatitis C. Response to treatment and side effects will be recorded.
Read the detailed description
The product is locally produced and needs to be evaluated in terms of efficacy and safety.
- Conditions
- Hepatitis C
- Being tested
- Pegaferon (pegylated interferon alpha 2a) + ribavirin
- Keywords
- Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegaferon (pegylated interferon alpha 2a) + ribavirinDrug
Also called Pegaferon
pegylated interferon 180 micrograms subcutaneously weekly - ribavirin (oral, in two divided daily doses) 800 mg for genotype 2 and 3, 1000 or 1200mg (weight less than or greater than 75kg) for genotypes 1 and 4 - Duration: 24 weeks for genotype 2 and 3, 48 weeks for genotypes 1 and 4
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: Pegaferon (pegylated interferon alpha 2a) + ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained viral response
Negative hepatitis C viral RNA with a highly sensitive assay 6 months after end of treatment
Measured: 6 months after end of treatment
Secondary outcomes (1)
Adverse drug events
Any adverse event reported by patient or seen in laboratory data
Measured: 18 months from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startDec 2007
- Primary completionDec 2009
- Study completionFeb 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Pars No Tarkib Co
- Investigators
- Reza Malekzadeh, MD, Study chair, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137383
- Sponsor's protocol ID
- DDRC.86.90
- Status last verified
- Jun 2010
- First submitted
- 3 Jun 2010
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Jabbari H, Bayatian A, Sharifi AH, Zaer-Rezaee H, Fakharzadeh E, Asadi R, Zamini H, Shahzamani K, Merat S, Nassiri-Toosi M. Safety and efficacy of locally manufactured pegylated interferon in hepatitis C patients. Arch Iran Med. 2010 Jul;13(4):306-12.
PubMed 20597564
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Locally Manufactured Pegylated Interferon in Hepatitis C Patients
- ClinicalTrials.gov ID
- NCT01137383
- Acronym / sponsor ID
- DDRC.86.90
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Pars No Tarkib Co
- Study start
- Dec 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 4 Jun 2010 (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.
The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be treated using standard guidelines for hepatitis C. Response to treatment and side effects will be recorded.
Detailed description
The product is locally produced and needs to be evaluated in terms of efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Pegaferon (pegylated interferon alpha 2a) + ribavirin |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic hepatitis C
- Age between 15 and 65
Key exclusion criteria (15 listed)
- previous treatment for chronic hepatitis C
- co-infection with human immunodeficiency virus or hepatitis B virus
- major thalassemia or hemophilia
- active drug user
- being treated for major depression or psychosis
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 |
|---|---|---|
| Pegaferon (pegylated interferon alpha 2a) + ribavirinAlso: Pegaferonpegylated interferon 180 micrograms subcutaneously weekly - ribavirin (oral, in two divided daily doses) 800 mg for genotype 2 and 3, 1000 or 1200mg (weight less than or greater than 75kg) for genotypes 1 and 4 - Duration: 24 weeks for genotype 2 and 3, 48 weeks for genotypes 1 and 4 | Drug | Treatment group |
Primary outcome
Sustained viral response
Time frame: 6 months after end of treatment
Negative hepatitis C viral RNA with a highly sensitive assay 6 months after end of treatment
1 secondary outcome
Adverse drug events
Time frame: 18 months from start 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 30 Jun 2010.
- Derived from this study: PubMed 20597564Jabbari H, Bayatian A, Sharifi AH, Zaer-Rezaee H, Fakharzadeh E, Asadi R, Zamini H, Shahzamani K, Merat S, Nassiri-Toosi M. Safety and efficacy of locally manufactured pegylated interferon in hepatitis C patients. Arch Iran Med. 2010 Jul;13(4):306-12.
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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.
Reza Malekzadeh, MD study chair
Tehran University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegaferon (pegylated interferon alpha 2a) + ribavirin in people with Hepatitis C, run by Tehran University of Medical Sciences at 2 sites 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 15 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 30 Jun 2010. 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 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?
Sustained viral response (time frame: 6 months after end 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 NCT01137383, 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 30 Jun 2010.