Hepatitis CPhase 1/2PLUSNCT00593151
Study of Safety, Tolerability, and Anti-Viral Effect of Locteron Compared to PEG-Intron in Patients With Chronic Hepatitis C
A Phase 1/2 study testing pegylated IFNa2b in people with Hepatitis C, run by Biolex Therapeutics, Inc. at 5 sites in United States.
Trial summary
The purposes of the PLUS study were to confirm the safety and tolerability of two doses of LocteronTM (320 ug and 640 ug) dosed over four weeks in patients who had failed prior anti-HCV therapies (Panels A and B), and then to continue to study the safety, tolerability, and preliminary efficacy of the same two doses of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- pegylated IFNa2b
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2008to Mar 2009
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of chronic hepatitis C
- Positive HCV RNA test with a level >= 1 x 104 IU/mL (by RT-PCR)
Who cannot join
- Decompensated Liver Disease
- Positive test for serum antibodies to the human immunodeficiency virus (HIV), hepatitis A (HAV-IgM), o hepatitis B (HBV- +Hepatitis B surface antigen)
- A history of severe psychiatric disease, including major depression
- A history of immunologically-mediated disease, COPD, severe asthma, severe cardiac disease, active cancer or cancer within last 5 years, seizures within the past 5 years or epilepsy, solid organ or bone marrow transplant, uncontrolled thyroid disease, or clinically significant retinopathy
- Pregnant or lactating females
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Inova Center for Liver Diseases
Annandale, Virginia, 22003
Methodist Dallas Medical Center
Dallas, Texas, 75208
Henry Ford Hospital
Detroit, Michigan, 48202
McGuire DVAMC, McGuire Research Institute
Richmond, Virginia, 23249
Alamo Medical Research
San Antonio, Texas, 78215
About this study
Official title: An Open-Label, 3-Panel, Dose-Escalation Study to Assess the Safety and Tolerability, Pharmacokinetics, and Viral Kinetics of Two Doses of LocteronTM (Poly ActiveTM - Interferon Alpha 2b) Given Every 2 Weeks for 4-12 Weeks in Comparison With PEG-Intron Given Weekly for 4-12 Weeks in Patients With Chronic Hepatitis C
The purposes of the PLUS study were to confirm the safety and tolerability of two doses of LocteronTM (320 ug and 640 ug) dosed over four weeks in patients who had failed prior anti-HCV therapies (Panels A and B), and then to continue to study the safety, tolerability, and preliminary efficacy of the same two doses of LocteronTM (320 ug and 640 ug) in treatment-naïve genotype 1 HCV patients when Locteron dosed over 12 weeks (Panel C). All subjects were also to receive oral daily weight-based ribavirin.
Read the detailed description
Panels A and B of the PLUS study were designed to assess the safety and tolerability, pharmacokinetics, and viral kinetics over four weeks of two doses of Locteron™ (230 ug and 640 ug) given every two weeks in comparison with PegIntron® given weekly in treatment-experienced subjects with chronic hepatitis C of any genotype who were co-administered weight-based oral ribavirin. The two cohorts of 16 subjects each in Panels A and B consisted of subjects who had failed prior interferon therapy. In Panel A, 8 subjects were randomized to and completed 4 weeks of treatment with 320 μg Locteron™ and 8 subjects were randomized to and completed 4 weeks of treatment with 1.5 ug/kg PegIntron®. In Panel B, 8 subjects were randomized to and completed 4 weeks of treatment with 640 μg Locteron™ and 8 subjects were randomized to and completed 4 weeks of treatment with 1.5 ug/kg PegIntron®. When the results of Panel A and Panel B were known, conduct of Panel C for 12 weeks in treatment-naive patients with chronic genotype-1 HCV was considered unnecessary and cancelled, and an entirely new study was begun instead.
- Conditions
- Hepatitis C
- Being tested
- Locteron (controlled-release interferon alpha 2b), pegylated IFNa2b
- Keywords
- Antimetabolites, Virus Diseases, Anti-Infective Agents, RNA Virus Infections, Digestive System Diseases, Flaviviridae Infections, Antineoplastic Agents, Therapeutic Uses, Antiviral Agents, Molecular Mechanisms of Action, Pharmacologic Actions
- Medical subject headings
- Hepatitis C, Virus Diseases, RNA Virus Infections, Digestive System Diseases, Flaviviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locteron (controlled-release interferon alpha 2b)Other
Also called PolyActive-IFNa2b, BLX-883+PolyActive
biological+device, bi-weekly subcutaneous injections for 4-12 weeks, 160 mcg per injection
pegylated IFNa2bBiological
Also called PEG-Intron, PEG, 12 kDalton pegylated interferon alpha 2b
biological, weekly subcutaneous injections for 4-12 weeks, 1.5 mcg/kg
| Study group | Role | What they receive |
|---|---|---|
| A, C, 320 mcg | Experimental | Bi-weekly subcutaneous doses of Locteron (controlled-release interferon alpha 2b) with oral ribavirin. Receives: Other: Locteron (controlled-release interferon alpha 2b) |
| B, C, 640 mcg | Experimental | Bi-weekly subcutaneous doses of Locteron (controlled-release interferon alpha 2b) with oral ribavirin. Receives: Other: Locteron (controlled-release interferon alpha 2b) |
| A, B, C PEG | Active comparator | Weekly subcutaneous injections of 1.5 ug/kg PegIntron (12 kDalton pegylated interferon alpha 2b) with oral ribavirin. Receives: Biological: pegylated IFNa2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess in subjects with chronic hepatitis C the safety and tolerability of Locteron in comparison with PEG-Intron.
Measured: 7 months (4 weeks of treatment, 6 months of follow up)
Secondary outcomes (1)
To assess in subjects with chronic hepatitis C receiving a weight-based oral daily dose of ribavirin: • The PK profile of Locteron (IFNa2b) • The preliminary efficacy of Locteron assessed by serial quantitation of HCV RNA levels
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionMar 2009
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolex Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Walker Long, MD, Study director, Biolex Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593151
- Sponsor's protocol ID
- S07-200-02-003
- Acronym
- PLUS
- Status last verified
- Feb 2012
- First submitted
- 2 Jan 2008
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lawitz E, Younossi ZM, Shiffman M, Gordon S, Ghalib R, Long W, Muir A, McHutchison J. Randomized trial comparing systemic and local reactions to controlled-release interferon alpha2b and pegylated-interferon alpha2b in hepatitis C subjects who failed prior treatment. J Hepatology 50:S231 (abstract 628), 2009. (Presented to the 44th Annual Meeting Of The European Association for the Study of the Liver, April 22-26, 2009.)
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, 3-Panel, Dose-Escalation Study to Assess the Safety and Tolerability, Pharmacokinetics, and Viral Kinetics of Two Doses of LocteronTM (Poly ActiveTM - Interferon Alpha 2b) Given Every 2 Weeks for 4-12 Weeks in Comparison With PEG-Intron Given Weekly for 4-12 Weeks in Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00593151
- Acronym / sponsor ID
- PLUS / S07-200-02-003
- Conditions
- Hepatitis C
- Keywords
- Antimetabolites, Virus Diseases, Anti-Infective Agents, RNA Virus Infections, Digestive System Diseases, Flaviviridae Infections, Antineoplastic Agents, Therapeutic Uses
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Biolex Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Jan 2008 (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 purposes of the PLUS study were to confirm the safety and tolerability of two doses of LocteronTM (320 ug and 640 ug) dosed over four weeks in patients who had failed prior anti-HCV therapies (Panels A and B), and then to continue to study the safety, tolerability, and preliminary efficacy of the same two doses of LocteronTM (320 ug and 640 ug) in treatment-naïve genotype 1 HCV patients when Locteron dosed over 12 weeks (Panel C). All subjects were also to receive oral daily weight-based ribavirin.
Detailed description
Panels A and B of the PLUS study were designed to assess the safety and tolerability, pharmacokinetics, and viral kinetics over four weeks of two doses of Locteron™ (230 ug and 640 ug) given every two weeks in comparison with PegIntron® given weekly in treatment-experienced subjects with chronic hepatitis C of any genotype who were co-administered weight-based oral ribavirin. The two cohorts of 16 subjects each in Panels A and B consisted of subjects who had failed prior interferon therapy. In Panel A, 8 subjects were randomized to and completed 4 weeks of treatment with 320 μg Locteron™ and 8 subjects were randomized to and completed 4 weeks of treatment with 1.5 ug/kg PegIntron®. In Panel B, 8 subjects were randomized to and completed 4 weeks of treatment with 640 μg Locteron™ and 8 subjects were randomized to and completed 4 weeks of treatment with 1.5 ug/kg PegIntron®. When the results of Panel A and Panel B were known, conduct of Panel C for 12 weeks in treatment-naive patients with chronic genotype-1 HCV was considered unnecessary and cancelled, and an entirely new study was begun instead.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A, C, 320 mcg | Experimental | Other: Locteron (controlled-release interferon alpha 2b)Bi-weekly subcutaneous doses of Locteron (controlled-release interferon alpha 2b) with oral ribavirin. |
| B, C, 640 mcg | Experimental | Other: Locteron (controlled-release interferon alpha 2b)Bi-weekly subcutaneous doses of Locteron (controlled-release interferon alpha 2b) with oral ribavirin. |
| A, B, C PEG | Active comparator | Biological: pegylated IFNa2bWeekly subcutaneous injections of 1.5 ug/kg PegIntron (12 kDalton pegylated interferon alpha 2b) with oral ribavirin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Evidence of chronic hepatitis C
- Positive HCV RNA test with a level >= 1 x 104 IU/mL (by RT-PCR)
Key exclusion criteria (5 listed)
- Decompensated Liver Disease
- Positive test for serum antibodies to the human immunodeficiency virus (HIV), hepatitis A (HAV-IgM), o hepatitis B (HBV- +Hepatitis B surface antigen)
- A history of severe psychiatric disease, including major depression
- A history of immunologically-mediated disease, COPD, severe asthma, severe cardiac disease, active cancer or cancer within last 5 years, seizures within the past 5 years or epilepsy, solid organ or bone marrow transplant, uncontrolled thyroid disease, or clinically significant retinopathy
- Pregnant or lactating females
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 |
|---|---|---|
| Locteron (controlled-release interferon alpha 2b)Also: PolyActive-IFNa2b, BLX-883+PolyActivebiological+device, bi-weekly subcutaneous injections for 4-12 weeks, 160 mcg per injection | Other | A, C, 320 mcg, B, C, 640 mcg |
| pegylated IFNa2bAlso: PEG-Intron, PEG, 12 kDalton pegylated interferon alpha 2bbiological, weekly subcutaneous injections for 4-12 weeks, 1.5 mcg/kg | Biological | A, B, C PEG |
Primary outcome
To assess in subjects with chronic hepatitis C the safety and tolerability of Locteron in comparison with PEG-Intron.
Time frame: 7 months (4 weeks of treatment, 6 months of follow up)
1 secondary outcome
To assess in subjects with chronic hepatitis C receiving a weight-based oral daily dose of ribavirin: • The PK profile of Locteron (IFNa2b) • The preliminary efficacy of Locteron assessed by serial quantitation of HCV RNA levels
Time frame: 4 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 3 Feb 2012.
- Results publicationLawitz E, Younossi ZM, Shiffman M, Gordon S, Ghalib R, Long W, Muir A, McHutchison J. Randomized trial comparing systemic and local reactions to controlled-release interferon alpha2b and pegylated-interferon alpha2b in hepatitis C subjects who failed prior treatment. J Hepatology 50:S231 (abstract 628), 2009. (Presented to the 44th Annual Meeting Of The European Association for the Study of the Liver, April 22-26, 2009.)
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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.
Walker Long, MD study director
Biolex Therapeutics, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing pegylated IFNa2b in people with Hepatitis C, run by Biolex Therapeutics, Inc. at 5 sites 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 2 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 3 Feb 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To assess in subjects with chronic hepatitis C the safety and tolerability of Locteron in comparison with PEG-Intron. (time frame: 7 months (4 weeks of treatment, 6 months of follow up)). 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 NCT00593151, 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 3 Feb 2012.