Substance-Related DisordersPhase 4NCT00194480
Treatment of Acute Hepatitis C Virus Infection With Pegylated Interferon in Injection Drug Users
A Phase 4 study testing Pegylated Interferon in people with Substance-Related Disorders and Hepatitis, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Injection drug use accounts for transmission of a high proportion of Hepatitis C Virus (HCV) infections. The purpose of this trial is to investigate the effectiveness of pegylated interferon in treating injection drug users (IDUs) with acute HCV. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Substance-Related Disorders, Hepatitis
- What is being tested?
- Pegylated Interferon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Jun 2007
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented HCV antibody seroconversion within the 12 months prior to study entry
- Serum positive for HCV
- Meets hematologic, biochemical, and serologic criteria at entry visit
- Thyroid stimulating hormone within normal limits
- Hepatitis B surface antigen negative
- Reads at an eighth grade reading level
- Willing to use adequate contraception for the duration of the study
- Plans to remain in the study area for 12 months
Who cannot join
- Positive test for Hepatitis A antibodies, Hepatitis B antibodies, or HIV antibodies
- Suspected hypersensitivity to pegylated interferon
- Liver disease
- Hemoglobinopathies
- Immune mediated disease
- Significant cardiac or pulmonary disease
Show all 14Show fewer
- Uncontrolled seizure disorder
- Renal insufficiency with serum creatinine levels greater than 11.5 mb/ml or less than 60 mb/ml
- History of thyroid disease
- Active gout
- Any medical condition requiring or likely to require steroids during the course of study
- Untreated severe psychiatric disorder, as determined by study psychiatrist
- Any condition, which in the opinion of the investigator, would preclude successful completion of the study
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center, 325 Ninth Ave 1EC32
Seattle, Washington, 98104
About this study
Official title: Treatment of Acute Hepatitis C Virus Infection in Injection Drug Users With Pegylated Interferon for 24 Weeks
Injection drug use accounts for transmission of a high proportion of Hepatitis C Virus (HCV) infections. The purpose of this trial is to investigate the effectiveness of pegylated interferon in treating injection drug users (IDUs) with acute HCV.
Read the detailed description
IDUs are at high risk for developing HCV. Pegylated interferon is a man-made form of interferon, a chemical naturally produced by the body that works to fight viruses. Interferon helps to stop HCV from replicating, and helps the immune system to kill HCV. The purpose of this trial is to determine the effectiveness of pegylated interferon in IDUs with HCV.
This trial will last 24 weeks. Participants will be randomly assigned to one of two groups. Group 1 will receive pegylated interferon while group 2 will receive an active control. Injection with either pegylated interferon or control will occur weekly. During each injection visit, participants will be asked about adverse events, including common side effects to interferon such as injection site reactions, headache, myalgias, arthralgias, insomnia, and hair loss. At Weeks 2, 4, and then every 4 weeks thereafter, participants will complete depression self-reports. Laboratory assessments will occur at Week 2, and then on a monthly basis for the remainder of the study. Follow-up assessments will occur every 4 weeks after Week 24.
- Conditions
- Substance-Related Disorders, Hepatitis
- Being tested
- Pegylated Interferon
- Keywords
- Hepatitis C, peg-Interferon, drug abuse
- Medical subject headings
- Substance-Related Disorders, Hepatitis, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated InterferonDrug
Weekly injections of pegIntereferon
| Study group | Role | What they receive |
|---|---|---|
| PegInterferon | Experimental | Arm 1: 24 weeks of weekly injections of peginterferon Arm 2: control (no treatment) Receives: Drug: Pegylated Interferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained viral response rate in treatment group versus control (measured at Week 24)
Measured: 24 weeks
Secondary outcomes (1)
Adherence rate in the treatment group (measured at Week 24)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionDec 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Washington
- Investigators
- Chia Wang, MD, MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194480
- Sponsor's protocol ID
- NIDA-16066-1
- Other IDs
- R21DA016066-01
- Status last verified
- Oct 2008
- First submitted
- 12 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acute Hepatitis C Virus Infection in Injection Drug Users With Pegylated Interferon for 24 Weeks
- ClinicalTrials.gov ID
- NCT00194480
- Acronym / sponsor ID
- NIDA-16066-1
- Conditions
- Substance-Related Disorders, Hepatitis
- Keywords
- Hepatitis C, peg-Interferon, drug abuse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- University of Washington
- Study start
- Apr 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 19 Sep 2005 (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.
Injection drug use accounts for transmission of a high proportion of Hepatitis C Virus (HCV) infections. The purpose of this trial is to investigate the effectiveness of pegylated interferon in treating injection drug users (IDUs) with acute HCV.
Detailed description
IDUs are at high risk for developing HCV. Pegylated interferon is a man-made form of interferon, a chemical naturally produced by the body that works to fight viruses. Interferon helps to stop HCV from replicating, and helps the immune system to kill HCV. The purpose of this trial is to determine the effectiveness of pegylated interferon in IDUs with HCV.
This trial will last 24 weeks. Participants will be randomly assigned to one of two groups. Group 1 will receive pegylated interferon while group 2 will receive an active control. Injection with either pegylated interferon or control will occur weekly. During each injection visit, participants will be asked about adverse events, including common side effects to interferon such as injection site reactions, headache, myalgias, arthralgias, insomnia, and hair loss. At Weeks 2, 4, and then every 4 weeks thereafter, participants will complete depression self-reports. Laboratory assessments will occur at Week 2, and then on a monthly basis for the remainder of the study. Follow-up assessments will occur every 4 weeks after Week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PegInterferon | Experimental | Drug: Pegylated InterferonArm 1: 24 weeks of weekly injections of peginterferon Arm 2: control (no treatment) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Documented HCV antibody seroconversion within the 12 months prior to study entry
- Serum positive for HCV
- Meets hematologic, biochemical, and serologic criteria at entry visit
- Thyroid stimulating hormone within normal limits
- Hepatitis B surface antigen negative
Key exclusion criteria (14 listed)
- Positive test for Hepatitis A antibodies, Hepatitis B antibodies, or HIV antibodies
- Suspected hypersensitivity to pegylated interferon
- Liver disease
- Hemoglobinopathies
- Immune mediated disease
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 InterferonWeekly injections of pegIntereferon | Drug | PegInterferon |
Primary outcome
Sustained viral response rate in treatment group versus control (measured at Week 24)
Time frame: 24 weeks
1 secondary outcome
Adherence rate in the treatment group (measured at Week 24)
Time frame: 24 weeks
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 12 Jan 2017.
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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.
Chia Wang, MD, MS principal investigator
University of Washington
1 site 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 in people with Substance-Related Disorders and Hepatitis, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
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 8 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 12 Jan 2017. 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 United States. 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 viral response rate in treatment group versus control (measured at Week 24) (time frame: 24 weeks). 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 12 Jan 2017.