Hepatitis CPhase 2NCT00097045
Omega Interferon Alone or in Combination With Ribavirin in Subjects With Hepatitis C
A Phase 2 study testing omega interferon and Ribavirin in people with Hepatitis C, run by Intarcia Therapeutics at 3 sites in Russia.
Trial summary
This study is designed to compare the safety, tolerability and antiviral effects of omega interferon administered alone to omega interferon administered with ribavirin in the treatment of subjects with chronic Hepatitis C virus (HCV) infection. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- omega interferon and Ribavirin
- How many people
- 90 participants
- Where
- 3 sitesRussia
- Study dates
- Nov 2004to Dec 2006
- Phase
- Phase 2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female
- Age 18 years to 64 years
- Signed and dated written informed consent form
- Infection with HCV genotype 1
- Two HCV RNA levels greater than or equal to 100,000 International Units per mL (IU/mL) at least seven days apart within 6 weeks prior to randomization
- One alanine aminotransferase level greater than the upper limit of normal between three months and twelve months prior to randomization
Show all 11Show fewer
- At least one alanine aminotransferase level greater than the upper limit of normal between three months and twelve months prior to randomization
- For the duration of treatment with study drug for all subjects and for the duration of treatment with study drug plus an additional six months for subjects who take ribavirin, attenuation of the potential of the subject to become pregnant, or to impregnate a sexual partner, by either:
- the use of an approved contraceptive method (e.g., IUD, oral contraceptive, or double-barrier method), or
- definitive exclusion by surgery, radiation, menopause or vasectomy
- For women of childbearing potential, negative serum Beta HCG pregnancy test within 14 days prior to randomization
Who cannot join
- Any additional plausible cause for chronic liver disease, including active infection by other viruses known or suspected to cause hepatitis
- Ascites or other current evidence of portal hypertension
- Child-Pugh classification B or C liver disease
- Clinically apparent jaundice or a total bilirubin exceeding 2 mg/dL (Subjects with Gilbert's Syndrome who meet all other inclusion and exclusion criteria may be admitted to the study with a total bilirubin greater than 2 mg/dL)
- Hemoglobin <12 g/dL
- A platelet count of less than 100,000 per mm3
Show all 25Show fewer
- A total white blood cell count of less than 3,000 per mm3
- An absolute neutrophil count of less than 1,500 per mm3
- Abnormal thyroid function (Subjects requiring thyroid replacement and who have stable, normal thyroid function may be admitted to the study)
- History of significant renal dysfunction
- History of significant or unstable cardiac disease
- Concurrent alcohol abuse or illicit drug use
- Pregnant or lactating women
- Male partners of women who are pregnant
- Prior usage of an interferon
- Concurrent usage of any antiviral therapy, including another interferon, during the study
- Any concurrent infectious disease requiring antimicrobial treatment
- Positive test for human immunodeficiency virus
- Positive test for illicit drugs
- A history of malignancy (except for previously cured squamous cell or basal cell carcinoma)
- Known hypersensitivity to interferons or ribavirin or related compounds
- A concurrent diagnosis of depression that has not been stable for at least 60 days prior to randomization
- Usage of an investigational drug within the 30 days prior to randomization; or the planned usage of an investigational drug other than omega interferon during the course of the current study
- Prior randomization to this study
- Any condition which, at the discretion of the investigator, would render an individual an inappropriate candidate for this study
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Phase 2 Study of Omega Interferon Alone or in Combination With Ribavirin in Subjects With Hepatitis C
This study is designed to compare the safety, tolerability and antiviral effects of omega interferon administered alone to omega interferon administered with ribavirin in the treatment of subjects with chronic Hepatitis C virus (HCV) infection.
Read the detailed description
Omega interferon is administered subcutaneously daily for up to 48 weeks.
- Conditions
- Hepatitis C
- Being tested
- omega interferon, Ribavirin
- Keywords
- Hepatitis C, HCV, Omega Interferon, Interferon, HCV genotype 1
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega interferonDrug
RibavirinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV RNA levels at clinically relevant timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2004 (estimated)
- Study startNov 2004
- Study completionDec 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Intarcia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097045
- Sponsor's protocol ID
- Biomed 510-CLP-07
- Status last verified
- Aug 2007
- First submitted
- 17 Nov 2004
- Last updated
- 23 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Omega Interferon Alone or in Combination With Ribavirin in Subjects With Hepatitis C
- ClinicalTrials.gov ID
- NCT00097045
- Acronym / sponsor ID
- Biomed 510-CLP-07
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, HCV, Omega Interferon, Interferon, HCV genotype 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- Intarcia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 18 Nov 2004 (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.
This study is designed to compare the safety, tolerability and antiviral effects of omega interferon administered alone to omega interferon administered with ribavirin in the treatment of subjects with chronic Hepatitis C virus (HCV) infection.
Detailed description
Omega interferon is administered subcutaneously daily for up to 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female
- Age 18 years to 64 years
- Signed and dated written informed consent form
- Infection with HCV genotype 1
- Two HCV RNA levels greater than or equal to 100,000 International Units per mL (IU/mL) at least seven days apart within 6 weeks prior to randomization
Key exclusion criteria (25 listed)
- Any additional plausible cause for chronic liver disease, including active infection by other viruses known or suspected to cause hepatitis
- Ascites or other current evidence of portal hypertension
- Child-Pugh classification B or C liver disease
- Clinically apparent jaundice or a total bilirubin exceeding 2 mg/dL (Subjects with Gilbert's Syndrome who meet all other inclusion and exclusion criteria may be admitted to the study with a total bilirubin greater than 2 mg/dL)
- Hemoglobin <12 g/dL
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 |
|---|---|---|
| omega interferon | Drug | – |
| Ribavirin | Drug | – |
Primary outcome
HCV RNA levels at clinically relevant timepoints
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 23 Aug 2007.
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
HCV Infection
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
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing omega interferon and Ribavirin in people with Hepatitis C, run by Intarcia Therapeutics at 3 sites in Russia.
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 11 inclusion and 25 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 23 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
HCV RNA levels at clinically relevant timepoints. 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 23 Aug 2007.