Hepatitis CPhase 4NCT00917358
Pegylated Interferon Alfa-2a for Dialysis Patients With Acute Hepatitis C
A Phase 4 study testing Pegylated interferon alfa-2a in people with Hepatitis C, run by National Taiwan University Hospital at 5 sites in Taiwan.
Trial summary
Interferon-based monotherapy has been considered effective to treat acute hepatitis C in ordinary patients. However, the efficacy of this treatment has not been evaluated in prospective interventional studies for dialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Pegylated interferon alfa-2a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 5 sitesTaiwan
- Study dates
- Jul 2005to Jun 2008
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old
- Creatinine clearance (Ccr) < 10 ml/min/1.73 m2
- Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive < 6 months with defined seroconversion
- Detectable serum quantitative HCV-RNA (Cobas Taqman HCV test, version 2, Roche Diagnostics) with a dynamic range of 25-391000000 IU/ml
Who cannot join
- Severe anemia (hemoglobin < 10 g/dL) or hemoglobinopathy
- Neutropenia (neutrophil count, <1,500/mm3)
- Thrombocytopenia (platelet <90,000/ mm3)
- Co-infection with HBV or HIV
- Chronic alcohol abuse (daily consumption > 20 g/day)
- Autoimmune liver disease
Show all 14Show fewer
- Decompensated liver disease (Child classification B or C)
- Neoplastic disease
- An organ transplant
- Immunosuppressive therapy
- Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
- Evidence of drug abuse
- Unwilling to have contraception
- Unwilling to sign inform consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Buddhist Tzu Chi General Hospital
Chiayi City
Chiayi Christian Hospital
Chiayi City
National Taiwan University Hospital, Yun-Lin Branch
Douliu
National Taiwan University Hospital
Taipei, 10002
Far Eastern Memorial Hospital
Taipei
About this study
Interferon-based monotherapy has been considered effective to treat acute hepatitis C in ordinary patients. However, the efficacy of this treatment has not been evaluated in prospective interventional studies for dialysis patients. The aim of the study is the evaluate the efficacy of peginterferon alfa-2a monotherapy for 24 weeks in this special clinical setting, and concomitantly evaluate retrospectively the dialysis patients with acute hepatitis C who did not receive intervention as the reference.
Read the detailed description
Chronic viral hepatitis is common in dialysis patients, with the reported prevalence and annual incidence of 3-80% and 2.9%, respectively. The high incidence and prevalence in thse patients are attributed to potential nosocomial exposure to hepatitis C virus during dialysis, resulting in high rates of acute hepatitis C virus infection. It is estimated that about 65-80% of the patients who have acute hepatitis C will evolve to chronic infection, leading to chronic hepatitis, cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC). Currently, interferon and pegylated interferon monotherapy remains effective to treat acute hepatitis C in ordinary patients, with the sustained virologic response (SVR) rates ranging from 65-90% after 12-24 weeks of therapy. However, few data regarding the efficacy and safety of interferon-based monotherapy is known till now. Treatment of weekly 135 pegylated interferon alfa-2a has shown superior safety to thrice weekly 3 million unit (MU) standard interferon alfa-2a for dialysis patients with chronic hepatitis C. Under the excellent safety profiles of treating dialysis patients with low dose pegylated interferon alfa-2a, we aimed to evaluate the efficacy of weekly 135 ug pegylated interferon alfa-2a for a total of 24 weeks for dialysis patients with acute hepatitis C, and also evaluate the SVR rate by retrospective chart review for dialysis patients with acute hepatitis C who did not receive interferon-based therapy to evaluate if early intervention for these patients will improve overall disease outcome.
- Conditions
- Hepatitis C
- Being tested
- Pegylated interferon alfa-2a
- Keywords
- Hepatitis C, Dialysis, Interferon
- 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 alfa-2aDrug
Also called Pegylated interferon alfa-2a (Pegasys, Hoffman-La Roche)
Pegylated interferon alfa-2a 135 ug/week for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pegylated interferon alfa-2a | Experimental | Pegylated interferon alfa-2a 135 ug/week for 24 weeks Receives: Drug: Pegylated interferon alfa-2a |
| Observation | No intervention | Retrospectively chart review of dialysis patients with acute hepatitis C who did not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response (SVR)
Measured: 1.0 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJul 2005
- Primary completionJun 2008
- Study completionJun 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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chen-Hua Liu, MD, Study chair, National Taiwan University HospitalJia-Horng Kao, MD, PhD, Principal investigator, National Taiwan University HospitalCheng-Chao Liang, MD, Principal investigator, Far Eastern Memorial HospitalShih-Jer Hsu, MD, Principal investigator, National Taiwan University Hospital, Yun-Lin BranchHung-Bin Tsai, MD, Principal investigator, Buddhist Tzu Chi General HospitalPeir-Haur Hung, MD, Principal investigator, Chiayi Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917358
- Sponsor's protocol ID
- 940215
- Status last verified
- Dec 2012
- First submitted
- 8 Jun 2009
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pegylated Interferon Alfa-2a for Dialysis Patients With Acute Hepatitis C
- ClinicalTrials.gov ID
- NCT00917358
- Acronym / sponsor ID
- 940215
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, Dialysis, Interferon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jul 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 Jun 2009 (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.
Interferon-based monotherapy has been considered effective to treat acute hepatitis C in ordinary patients. However, the efficacy of this treatment has not been evaluated in prospective interventional studies for dialysis patients. The aim of the study is the evaluate the efficacy of peginterferon alfa-2a monotherapy for 24 weeks in this special clinical setting, and concomitantly evaluate retrospectively the dialysis patients with acute hepatitis C who did not receive intervention as the reference.
Detailed description
Chronic viral hepatitis is common in dialysis patients, with the reported prevalence and annual incidence of 3-80% and 2.9%, respectively. The high incidence and prevalence in thse patients are attributed to potential nosocomial exposure to hepatitis C virus during dialysis, resulting in high rates of acute hepatitis C virus infection. It is estimated that about 65-80% of the patients who have acute hepatitis C will evolve to chronic infection, leading to chronic hepatitis, cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC). Currently, interferon and pegylated interferon monotherapy remains effective to treat acute hepatitis C in ordinary patients, with the sustained virologic response (SVR) rates ranging from 65-90% after 12-24 weeks of therapy. However, few data regarding the efficacy and safety of interferon-based monotherapy is known till now. Treatment of weekly 135 pegylated interferon alfa-2a has shown superior safety to thrice weekly 3 million unit (MU) standard interferon alfa-2a for dialysis patients with chronic hepatitis C. Under the excellent safety profiles of treating dialysis patients with low dose pegylated interferon alfa-2a, we aimed to evaluate the efficacy of weekly 135 ug pegylated interferon alfa-2a for a total of 24 weeks for dialysis patients with acute hepatitis C, and also evaluate the SVR rate by retrospective chart review for dialysis patients with acute hepatitis C who did not receive interferon-based therapy to evaluate if early intervention for these patients will improve overall disease outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegylated interferon alfa-2a | Experimental | Drug: Pegylated interferon alfa-2aPegylated interferon alfa-2a 135 ug/week for 24 weeks |
| Observation | No intervention | –Retrospectively chart review of dialysis patients with acute hepatitis C who did not receive any intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years old
- Creatinine clearance (Ccr) < 10 ml/min/1.73 m2
- Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive < 6 months with defined seroconversion
- Detectable serum quantitative HCV-RNA (Cobas Taqman HCV test, version 2, Roche Diagnostics) with a dynamic range of 25-391000000 IU/ml
Key exclusion criteria (14 listed)
- Severe anemia (hemoglobin < 10 g/dL) or hemoglobinopathy
- Neutropenia (neutrophil count, <1,500/mm3)
- Thrombocytopenia (platelet <90,000/ mm3)
- Co-infection with HBV or HIV
- Chronic alcohol abuse (daily consumption > 20 g/day)
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 alfa-2aAlso: Pegylated interferon alfa-2a (Pegasys, Hoffman-La Roche)Pegylated interferon alfa-2a 135 ug/week for 24 weeks | Drug | Pegylated interferon alfa-2a |
Primary outcome
Sustained virologic response (SVR)
Time frame: 1.0 year
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 20 Dec 2012.
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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.
Chen-Hua Liu, MD study chair
National Taiwan University Hospital
Jia-Horng Kao, MD, PhD principal investigator
National Taiwan University Hospital
Cheng-Chao Liang, MD principal investigator
Far Eastern Memorial Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegylated interferon alfa-2a in people with Hepatitis C, run by National Taiwan University Hospital at 5 sites in Taiwan.
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 4 inclusion and 14 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 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. 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?
Sustained virologic response (SVR) (time frame: 1.0 year). 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 20 Dec 2012.