Hepatitis C, ChronicPhase 2480SNCT00953589
480 STUDY: Phase 2b Study of Locteron Plus Ribavirin to Treat Hepatitis C Virus (HCV)
A Phase 2 study testing ribavirin in people with Hepatitis C, Chronic, run by Biolex Therapeutics, Inc. at 15 sites in 3 countries.
Trial summary
The purpose of this 12-week study was to assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the early virologic response to the 480 ug dose level of Locteron™, dosed every 2 weeks, in comparison with 1.5 ug/kg PEG-Intron™ dosed weekly. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Jul 2009to Jan 2011
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects 18 through 69 years of age, inclusive
- Chronic hepatitis C genotype 1
- HCV ribonucleic acid (RNA) level > 10,000 IU/mL (by RT-PCR) at screening
- Creatine clearance ≥ 50 mL/min
- Neutrophil count > 1500 cells/mm3
- Platelet count > 90,000/mm3
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- Hemoglobin > 12 g/dL for females and > 13 g/dL for males
- Female subjects of child-bearing potential agreeing to use dual methods for contraception
- Male subjects with female sexual partners agreeing to use effective birth control methods
- Negative serum pregnancy test for women of child-bearing potential
- Compensated liver disease defined as INR < 1.5, conjugated bilirubin < 1.5 x ULN, serum albumin > 3.0 g/dL
- Histologic evidence of Chronic Hepatitis C (CHC) (inflammation, fibrosis and/or cirrhosis on a standardized histologic grading system) as shown by biopsy within 2 years of screening or agrees to have a liver biopsy performed prior to randomization.
Who cannot join
- Prior antiviral treatment for hepatitis C
- Co-infection with HIV or hepatitis B virus
- Subjects with a body mass index (BMI) above 32 kg/m2
- Current or prior history of clinical hepatic decompensation
- Evidence of HCC
- Uncontrolled diabetes mellitus as evidenced by HbA1C ≥ 8.5% at screening
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- Known hypersensitivity to interferon alfa or ribavirin
- Chronic liver disease other than HCV
- Clinically significant hemoglobinopathy
- History of moderate, severe or uncontrolled psychiatric disease including depression and prior suicide attempts
- History of immune-mediated disease
- Significant renal or neurological disease
- Severe degree (> GOLD stage III) of chronic pulmonary disease (COPD) or active, severe asthma
- Subjects with severe cardiac disease
- History of significant central nervous system (including CNS trauma) or seizure disorders
- Cancer within the last 5 years, or previous cancer with a high risk of recurrence
- History of solid organ or bone marrow transplantation
- Clinical or laboratory evidence of uncontrolled thyroid disease, e.g., by thyroid stimulating hormone (TSH) level > 1.2 x upper limit of normal
- Clinically significant retinopathy; this needs to have been excluded by an eye exam performed by an ophthalmologist within the last 6 months prior to screening for subjects with hypertension or diabetes mellitus
- Drug abuse or alcohol consumption within the last 6 months which, in the opinion of the investigator, may affect study participation or outcome. Subjects in a supervised methadone treatment program on a stable regimen for > 6 months may be considered
- Taken any experimental agent within 12 weeks prior to screening
- More than 30 days of systemic immunosuppressive medication to include steroids in doses equivalent to or greater than 10 mg prednisone per day within 30 days prior to screening (inhaled corticosteroids are allowed)
- Nursing mother or male partner of pregnant female.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
Bulgaria6 sites
Tokuda Hospital
Sofia, 1407
UMHAT "Alexandrovska"
Sofia, 1431
UMHAT "St Ivan Rilski"
Sofia, 1431
UMHAT "Queen Giovanna - ISUL" EAD
Sofia, 1527
Medical Institute Ministry of Interior
Sofia, 1606
UMHAT "St Maria"
Varna, 9010
Israel5 sites
Carmel Medical Center
Haifa, 34341
Holy Family Hospital Nazareth
Nazareth, 16100
Rabin Medical Center
Petah Tikva, 49100
Rebekah Ziv Medical Center Safed
Safed, 13100
Sourasky Medical Center
Tel Aviv, 64239
Romania4 sites
Institute of Infectious Diseases
Bucharest, 021105
Fundeni Clinical Institute
Bucharest, 022328
"Victor Babes" Clinical Hospital Craiova
Craiova, 200515
Gastroenterology and Hepatology Institute
Iași, 700111
About this study
Official title: 480 STUDY: Phase 2b Open-label, Randomized Study in Treatment Naïve Subjects With HCV G1 to Compare the Efficacy, Safety, and Tolerability of the 480 µg Dose of Locteron™ Plus Ribavirin Given Bi-Weekly to PEG-Intron™ Plus Ribavirin Given Weekly
The purpose of this 12-week study was to assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the early virologic response to the 480 ug dose level of Locteron™, dosed every 2 weeks, in comparison with 1.5 ug/kg PEG-Intron™ dosed weekly.
Read the detailed description
The aim of the 480 STUDY was to compare efficacy and safety of 480ug Locteron dosed every other week to 1.5 ug/kg PegIntron dosed weekly in treatment-naïve genotype-1 chronic HCV subjects treated with weight-based ribavirin. This 12-week study was comprised of two panels (Panel A and Panel B). The designs of both panels were identical. HCV RNA was measured weekly for three weeks and then every other week. Adverse events including flu-like events and depression were collected during weekly clinic visits for 12 weeks. Flu-like events were also collected daily for 12 weeks by subject self-report using the internet (ePRO). Beck Depression Inventory (BDI) and Short Form-36 scores were measured at baseline and monthly through Week 12.
In Panel A of 480 STUDY, 42 treatment-naïve subjects with chronic genotype-1 HCV in Bulgaria and Romania were randomized and dosed with either Locteron q2weeks or weekly PegIntron, both in combination with weight-based ribavirin (13). In Panel A, 19 subjects received 480ug Locteron and 23 subjects received PegIntron.
In Panel B of 480 STUDY, 32 treatment-naïve subjects with genotype-1 HCV in Israel were randomized and dosed with either Locteron q2weeks or weekly PegIntron, both in combination with weight-based ribavirin (13). In Panel B, 16 subjects received 480ug Locteron and 16 subjects received PegIntron.
- Conditions
- Hepatitis C, Chronic
- Being tested
- ribavirin
- Keywords
- treatment naive
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ribavirinDrug
Also called Ribasphere
Ribavirin - oral administration Subjects with body weight < 65 kg: 800 mg/day Subjects with body weight 65-85 kg: 1000 mg/day Subjects with body weight 86-105 kg: 1200 mg/day Subjects with body weight > 105 kg: 1400 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Locteron ® PANEL A | Experimental | PANEL A: Locteron™ 480 µg dosed every 2 weeks in two subcutaneous injections (160 µg and 320 µg) Receives: Drug: ribavirin |
| Locteron ® PANEL B | Experimental | PANEL B: Locteron™ 480 µg dosed every two weeks in single subcutaneous injections Receives: Drug: ribavirin |
| PEG-Intron® PANEL A | Active comparator | PEG-Intron® 1.5 µg/kg body weight weekly subcutaneous injection Receives: Drug: ribavirin |
| PEG-Intron® PANEL B | Active comparator | PEG-Intron® 1.5 µg/kg body weight weekly subcutaneous injection Receives: Drug: ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint: EVR: the proportion of subjects in each arm that have at least a 2 log drop in HCV RNA from Baseline
Measured: Week 12
Secondary outcomes (1)
the proportion of subjects in each arm demonstrating HCV RNA undetectable (< 10 IU/mL) after 12 weeks of randomized treatment
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2010
- Study completionJan 2011
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 C, ChronicStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolex Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Walker A. Long, MD, Study director, Biolex Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953589
- Sponsor's protocol ID
- BLX883-204
- Acronym
- 480S
- Status last verified
- Feb 2012
- First submitted
- 5 Aug 2009
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Krastev Z, Kotzev I, Tchernev K, Rigney A, Nikolovska D, Vladimirov B, Caruntu FA, Diaconescu IG, Voiculescu XX, Long, WA. Randomized, open-label, 12-week comparison of controlled-release interferon alpha2b + ribavirin vs. pegylated interferon alpha 2b +ribavirin in treatment-naïve genotype1 hepatitis C: 4 week results from 480STUDY (Panel A). J Hepatology 52:S27 (abstract 58), 2010. (Presented to 45th Annual Meeting of the European Association for the Study of the Liver, April 16, 2010, Vienna, Austria.)
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 480 STUDY: Phase 2b Open-label, Randomized Study in Treatment Naïve Subjects With HCV G1 to Compare the Efficacy, Safety, and Tolerability of the 480 µg Dose of Locteron™ Plus Ribavirin Given Bi-Weekly to PEG-Intron™ Plus Ribavirin Given Weekly
- ClinicalTrials.gov ID
- NCT00953589
- Acronym / sponsor ID
- 480S / BLX883-204
- Conditions
- Hepatitis C, Chronic
- Keywords
- treatment naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Biolex Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Aug 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.
The purpose of this 12-week study was to assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the early virologic response to the 480 ug dose level of Locteron™, dosed every 2 weeks, in comparison with 1.5 ug/kg PEG-Intron™ dosed weekly.
Detailed description
The aim of the 480 STUDY was to compare efficacy and safety of 480ug Locteron dosed every other week to 1.5 ug/kg PegIntron dosed weekly in treatment-naïve genotype-1 chronic HCV subjects treated with weight-based ribavirin. This 12-week study was comprised of two panels (Panel A and Panel B). The designs of both panels were identical. HCV RNA was measured weekly for three weeks and then every other week. Adverse events including flu-like events and depression were collected during weekly clinic visits for 12 weeks. Flu-like events were also collected daily for 12 weeks by subject self-report using the internet (ePRO). Beck Depression Inventory (BDI) and Short Form-36 scores were measured at baseline and monthly through Week 12.
In Panel A of 480 STUDY, 42 treatment-naïve subjects with chronic genotype-1 HCV in Bulgaria and Romania were randomized and dosed with either Locteron q2weeks or weekly PegIntron, both in combination with weight-based ribavirin (13). In Panel A, 19 subjects received 480ug Locteron and 23 subjects received PegIntron.
In Panel B of 480 STUDY, 32 treatment-naïve subjects with genotype-1 HCV in Israel were randomized and dosed with either Locteron q2weeks or weekly PegIntron, both in combination with weight-based ribavirin (13). In Panel B, 16 subjects received 480ug Locteron and 16 subjects received PegIntron.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Locteron ® PANEL A | Experimental | Drug: ribavirinPANEL A: Locteron™ 480 µg dosed every 2 weeks in two subcutaneous injections (160 µg and 320 µg) |
| Locteron ® PANEL B | Experimental | Drug: ribavirinPANEL B: Locteron™ 480 µg dosed every two weeks in single subcutaneous injections |
| PEG-Intron® PANEL A | Active comparator | Drug: ribavirinPEG-Intron® 1.5 µg/kg body weight weekly subcutaneous injection |
| PEG-Intron® PANEL B | Active comparator | Drug: ribavirinPEG-Intron® 1.5 µg/kg body weight weekly subcutaneous injection |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female subjects 18 through 69 years of age, inclusive
- Chronic hepatitis C genotype 1
- HCV ribonucleic acid (RNA) level > 10,000 IU/mL (by RT-PCR) at screening
- Creatine clearance ≥ 50 mL/min
- Neutrophil count > 1500 cells/mm3
Key exclusion criteria (23 listed)
- Prior antiviral treatment for hepatitis C
- Co-infection with HIV or hepatitis B virus
- Subjects with a body mass index (BMI) above 32 kg/m2
- Current or prior history of clinical hepatic decompensation
- Evidence of HCC
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 |
|---|---|---|
| ribavirinAlso: RibasphereRibavirin - oral administration Subjects with body weight < 65 kg: 800 mg/day Subjects with body weight 65-85 kg: 1000 mg/day Subjects with body weight 86-105 kg: 1200 mg/day Subjects with body weight > 105 kg: 1400 mg/day | Drug | Locteron ® PANEL A, Locteron ® PANEL B, PEG-Intron® PANEL A, PEG-Intron® PANEL B |
Primary outcome
Primary efficacy endpoint: EVR: the proportion of subjects in each arm that have at least a 2 log drop in HCV RNA from Baseline
Time frame: Week 12
1 secondary outcome
the proportion of subjects in each arm demonstrating HCV RNA undetectable (< 10 IU/mL) after 12 weeks of randomized treatment
Time frame: Week 12
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 2 Feb 2012.
- BackgroundKrastev Z, Kotzev I, Tchernev K, Rigney A, Nikolovska D, Vladimirov B, Caruntu FA, Diaconescu IG, Voiculescu XX, Long, WA. Randomized, open-label, 12-week comparison of controlled-release interferon alpha2b + ribavirin vs. pegylated interferon alpha 2b +ribavirin in treatment-naïve genotype1 hepatitis C: 4 week results from 480STUDY (Panel A). J Hepatology 52:S27 (abstract 58), 2010. (Presented to 45th Annual Meeting of the European Association for the Study of the Liver, April 16, 2010, Vienna, Austria.)
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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 A. Long, MD study director
Biolex Therapeutics
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ribavirin in people with Hepatitis C, Chronic, run by Biolex Therapeutics, Inc. at 15 sites in 3 countries.
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 12 inclusion and 23 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 2 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 15 sites in Bulgaria, Israel, Romania. 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?
Primary efficacy endpoint: EVR: the proportion of subjects in each arm that have at least a 2 log drop in HCV RNA from Baseline (time frame: Week 12). 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 NCT00953589, 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 2 Feb 2012.