Hepatitis CPhase 2NCT00315432
NATURAL HISTORY-Hepatitis C Virus/ Human Immunodeficiency Virus Coinfection
A Phase 2 study testing Pegylated Interferon and Ribavirin in people with Hepatitis C and HIV, run by Ortho Biotech Products, L.P..
Trial summary
The purpose of this study was to describe the time course and extent of hemoglobin (Hb) changes and the erythropoietic response to PEG-IFN/RBV (Pegylated Interferon and Ribavirin)-induced anemia In HCV(hepatitis C virus)/HIV (human immunodeficiency virus) co-Infected subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis C, HIV, Anemia
- What is being tested?
- Pegylated Interferon and Ribavirin
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Nov 2003
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV- infected patients confirmed by HIV-RNA level
- HCV- infected patients confirmed by PCR(polymerase chain reaction) or branched DNA (b-DNA)
- Scheduled to commence combination IFN/RBV therapy on Day 1
- Normal serum creatinine
- On stable antiretroviral regimen (for HIV) for at least 4 weeks
- Life expectancy > 6 months
Who cannot join
- Patients with history of any primary hematologic disease
- Anemia attributable to factors such as iron or folate deficiency, pre-treatment
- hemolysis or gastrointestinal bleeding
- Has suspected or confirmed significant hepatic disease from an etiology other than
- HCV (e.g. alcohol, HBV DNA, autoimmune disease etc)
About this study
Official title: )A Study to Evaluate the Erythropoietic Response in HCV/HIV Co-Infected Patients Receiving Combination Ribavirin/Interferon Therapy
The purpose of this study was to describe the time course and extent of hemoglobin (Hb) changes and the erythropoietic response to PEG-IFN/RBV (Pegylated Interferon and Ribavirin)-induced anemia In HCV(hepatitis C virus)/HIV (human immunodeficiency virus) co-Infected subjects.
Read the detailed description
Patients receiving combination therapy for chronic hepatitis C virus (HCV) infection (standard or pegylated interferon alfa [PEG-IFN] in combination with ribavirin [RBV]) frequently develop moderate to severe anemia. In large, prospective, clinical trials of PEG-IFN alfa-2b and PEG-IFN alfa-2a, the reported mean decreases in hemoglobin (Hb) were 2.5 g/dL, and 3.7 g/dL, respectively. Furthermore, in a retrospective study, 54% of standard interferon/RBV-treated patients had hemoglobin decreases of at least 3 g/dL. It is important to understand the causes, natural history, and risk factors associated with HCV therapy-induced anemia, because such decreases in hemoglobin can result in RBV dose reduction or discontinuation, which may decrease the likelihood of a virologic response by patient. Erythropoietin is an endogenous hormone that acts in the bone marrow to increase the number of erythroid progenitor cells (red blood cells). Normally, a decrease in the hemoglobin level is accompanied by an increase in the serum erythropoietin (sEPO) level, which will ultimately normalize the Hemoglobin level. The relationship between hemoglobin and serum erythropoietin is less apparent in patients with chronic diseases such as cancer and human immunodeficiency virus (HIV) infection. It is not known whether HCV/HIV co-infected patients receiving combination PEG-IFN/RBV therapy have a similarly diminished erythropoietic response to anemia. The objective of this study is to document the pattern of hemoglobin changes and erythropoietic response (from baseline to final assessment) in HCV/HIV co-infected patients receiving combination therapy with IFN / RBV. N/A
- Conditions
- Hepatitis C, HIV, Anemia
- Being tested
- Pegylated Interferon and Ribavirin
- Keywords
- Natural History, Hepatitis C Infection, HIV Infection, HCV/HIV co-infection Ribavirin, Pegylated Interferon, Interferon
- Medical subject headings
- Hepatitis C, Anemia, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Interferon and RibavirinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoints were change in hemoglobin and serum erythropoietin from baseline to week 8 (or early withdrawal)
Secondary outcomes (1)
Other endpoints measured were changes in reticulocytes, platelets, total bilirubin, and RBV dose from baseline to week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2006 (estimated)
- Study startSep 2000
- Study completionNov 2003
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho Biotech Products, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ortho Biotech Products, L.P. Clinical Trial, Study director, Ortho Biotech Products, L.P.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315432
- Sponsor's protocol ID
- CR005134
- Status last verified
- Apr 2010
- First submitted
- 14 Apr 2006
- Last updated
- 19 May 2011
- Results posted
- No
Publications
Henry DH, Slim J, Lamarca A, Bowers P, Leitz G; HIV/HCV Coinfection Natural History Study Group. Natural history of anemia associated with interferon/ribavirin therapy for patients with HIV/HCV coinfection. AIDS Res Hum Retroviruses. 2007 Jan;23(1):1-9. doi: 10.1089/aid.2006.0082.
PubMed 17263626
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- )A Study to Evaluate the Erythropoietic Response in HCV/HIV Co-Infected Patients Receiving Combination Ribavirin/Interferon Therapy
- ClinicalTrials.gov ID
- NCT00315432
- Acronym / sponsor ID
- CR005134
- Conditions
- Hepatitis C, HIV, Anemia
- Keywords
- Natural History, Hepatitis C Infection, HIV Infection, HCV/HIV co-infection Ribavirin, Pegylated Interferon, Interferon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Ortho Biotech Products, L.P.Industry (pharma, biotech, devices)
- Study start
- Sep 2000
- Study completion
- Nov 2003 (actual)
- First posted
- 18 Apr 2006 (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 was to describe the time course and extent of hemoglobin (Hb) changes and the erythropoietic response to PEG-IFN/RBV (Pegylated Interferon and Ribavirin)-induced anemia In HCV(hepatitis C virus)/HIV (human immunodeficiency virus) co-Infected subjects.
Detailed description
Patients receiving combination therapy for chronic hepatitis C virus (HCV) infection (standard or pegylated interferon alfa [PEG-IFN] in combination with ribavirin [RBV]) frequently develop moderate to severe anemia. In large, prospective, clinical trials of PEG-IFN alfa-2b and PEG-IFN alfa-2a, the reported mean decreases in hemoglobin (Hb) were 2.5 g/dL, and 3.7 g/dL, respectively. Furthermore, in a retrospective study, 54% of standard interferon/RBV-treated patients had hemoglobin decreases of at least 3 g/dL. It is important to understand the causes, natural history, and risk factors associated with HCV therapy-induced anemia, because such decreases in hemoglobin can result in RBV dose reduction or discontinuation, which may decrease the likelihood of a virologic response by patient. Erythropoietin is an endogenous hormone that acts in the bone marrow to increase the number of erythroid progenitor cells (red blood cells). Normally, a decrease in the hemoglobin level is accompanied by an increase in the serum erythropoietin (sEPO) level, which will ultimately normalize the Hemoglobin level. The relationship between hemoglobin and serum erythropoietin is less apparent in patients with chronic diseases such as cancer and human immunodeficiency virus (HIV) infection. It is not known whether HCV/HIV co-infected patients receiving combination PEG-IFN/RBV therapy have a similarly diminished erythropoietic response to anemia. The objective of this study is to document the pattern of hemoglobin changes and erythropoietic response (from baseline to final assessment) in HCV/HIV co-infected patients receiving combination therapy with IFN / RBV. N/A
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV- infected patients confirmed by HIV-RNA level
- HCV- infected patients confirmed by PCR(polymerase chain reaction) or branched DNA (b-DNA)
- Scheduled to commence combination IFN/RBV therapy on Day 1
- Normal serum creatinine
- On stable antiretroviral regimen (for HIV) for at least 4 weeks
Key exclusion criteria (5 listed)
- Patients with history of any primary hematologic disease
- Anemia attributable to factors such as iron or folate deficiency, pre-treatment
- hemolysis or gastrointestinal bleeding
- Has suspected or confirmed significant hepatic disease from an etiology other than
- HCV (e.g. alcohol, HBV DNA, autoimmune disease etc)
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 and Ribavirin | Drug | – |
Primary outcome
Primary endpoints were change in hemoglobin and serum erythropoietin from baseline to week 8 (or early withdrawal)
1 secondary outcome
Other endpoints measured were changes in reticulocytes, platelets, total bilirubin, and RBV dose from baseline to week 8.
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 19 May 2011.
- Derived from this study: PubMed 17263626Henry DH, Slim J, Lamarca A, Bowers P, Leitz G; HIV/HCV Coinfection Natural History Study Group. Natural history of anemia associated with interferon/ribavirin therapy for patients with HIV/HCV coinfection. AIDS Res Hum Retroviruses. 2007 Jan;23(1):1-9. doi: 10.1089/aid.2006.0082.
- A Study to Evaluate the Erythropoietic Response in HCV/HIV Co-Infected Patients Receiving Combination Ribavirin/Interferon Therapy or Ribavirin/PEG-InterferonLink provided by the sponsor.
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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.
Ortho Biotech Products, L.P. Clinical Trial study director
Ortho Biotech Products, L.P.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegylated Interferon and Ribavirin in people with Hepatitis C and HIV, run by Ortho Biotech Products, L.P..
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 6 inclusion and 5 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 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Primary endpoints were change in hemoglobin and serum erythropoietin from baseline to week 8 (or early withdrawal). 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 NCT00315432, 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 19 May 2011.