Hepatitis CPhase 1NCT00372983
Safety and PK Study of NOV-205 to Treat Chronic HCV Who Fail Standard Therapy
A Phase 1 study testing NOV-205 in people with Hepatitis C, run by Cellectar Biosciences, Inc..
Trial summary
The purpose of this research trial is to find out whether NOV-205 is well tolerated compared to placebo (salt water) in people with hepatitis C. In addition, this trial will test how NOV-205 is absorbed by your body after single and multiple doses of the trial drug, and it will look for early signs of therapeutic… 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?
- NOV-205
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Dec 2007
- Phase
- Phase 1
- 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
- A serum HCV RNA level of >100,000 IU/ml using a quantitative, branched-chain-DNA (bDNA)-based assay (lower limit of quantitation = ~650 IU/ml) or other equally sensitive quantitative methods.
- Infection with genotype 1 HCV
- Documented failure to respond to treatment (defined as a patient who did not achieve an early viral response (EVR) (≥2 log reduction in serum HCV RNA or undetectable HCV RNA after 12 weeks of treatment) OR is serum HCV RNA positive after 24 weeks of treatment with pegylated interferon plus ribavirin for hepatitis C.
- Women of childbearing potential willing to use two acceptable methods of birth control during trial participation or are sterile or post-menopausal (defined as not having a menstrual cycle for greater than two years)
- Sexually active male subjects are practicing acceptable methods of contraception during trial participation
- Have the ability to understand the requirements of the trial, have provided written informed consent, and agree to abide by the trial restrictions and to return for the required assessments
- The subject must be able to self administer daily subcutaneous injections or their caregiver must be able to administer daily subcutaneous injections
Who cannot join
- Clinical, laboratory, or histological evidence of liver cirrhosis
- Evidence of hepatic decompensation (presence of or a history of ascites, hepatic encephalopathy, variceal bleeding, or hepatocellular carcinoma)
- Co-infection with human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) (as determined by presence of hepatitis B surface antigen (HBsAg)
- Have received pegylated interferon and/or ribavirin within the 60 days prior to randomization
- Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol
- Pregnant female or nursing mother
About this study
Official title: A Randomized, Placebo Controlled, Phase 1b Trial to Evaluate the Safety and Pharmacokinetics of NOV-205 in Chronic Viral Hepatitis C Subjects (Genotype 1) Who Have Failed Treatment With Pegylated Interferon Plus Ribavirin
The purpose of this research trial is to find out whether NOV-205 is well tolerated compared to placebo (salt water) in people with hepatitis C. In addition, this trial will test how NOV-205 is absorbed by your body after single and multiple doses of the trial drug, and it will look for early signs of therapeutic activity (decreases in indicators in the blood for the hepatitis C virus and for liver damage). This is known as pharmacokinetics (PK). NOV-205 is an experimental drug. "Experimental" means that the trial drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA). However, NOV-205 has been approved by the Russian Federation for treatment of liver diseases including hepatitis C. Clinical studies in that country showed that subjects treated with NOV-205 alone had decreased indicators in the blood for the hepatitis C virus and for liver damage.
Read the detailed description
This Phase 1b trial aims to evaluate the pharmacokinetic profile of NOV-205, and in comparison to placebo, identify early signs of antiviral activity (with a quantitative reduction of >0.5 log10 in serum HCV RNA level (Elbeik, 2004)) and establish a safety profile of NOV-205 as monotherapy in subjects with chronic HCV who are non-responders to treatment with pegylated interferon plus ribavirin. This trial will also explore the effect of NOV-205 on serum biochemical markers of liver damage (e.g. alanine aminotransferase, ALT) as indications of biologic activity. Results of this trial will guide the design of future Phase 2 studies of NOV-205 in chronic hepatitis C subjects.
- Conditions
- Hepatitis C
- Being tested
- NOV-205
- Keywords
- chronic HCV, Failed treatment, genotype 1, failed treatment with pegylated interferon plus ribavirin
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOV-205Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacokinetic profile of different dosing regimens of NOV-205.
To establish the safety profile of NOV-205 in comparison to that of placebo.
To compare changes in viral load after treatment with NOV-205 or placebo (as evidenced by a quantitative reduction of >0.5 log10 in serum HCV RNA levels by quantitative analysis as compared to the average of the screening and baseline values).
To evaluate the impact of NOV-205 on serum ALT and AST levels in comparison to that of placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startAug 2006
- Study completionDec 2007
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cellectar Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Raymond Koff, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372983
- Sponsor's protocol ID
- NOV205-C101
- Status last verified
- Dec 2007
- First submitted
- 5 Sep 2006
- Last updated
- 21 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Phase 1b Trial to Evaluate the Safety and Pharmacokinetics of NOV-205 in Chronic Viral Hepatitis C Subjects (Genotype 1) Who Have Failed Treatment With Pegylated Interferon Plus Ribavirin
- ClinicalTrials.gov ID
- NCT00372983
- Acronym / sponsor ID
- NOV205-C101
- Conditions
- Hepatitis C
- Keywords
- chronic HCV, Failed treatment, genotype 1, failed treatment with pegylated interferon plus ribavirin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cellectar Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Dec 2007 (actual)
- First posted
- 7 Sep 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 research trial is to find out whether NOV-205 is well tolerated compared to placebo (salt water) in people with hepatitis C. In addition, this trial will test how NOV-205 is absorbed by your body after single and multiple doses of the trial drug, and it will look for early signs of therapeutic activity (decreases in indicators in the blood for the hepatitis C virus and for liver damage). This is known as pharmacokinetics (PK). NOV-205 is an experimental drug. "Experimental" means that the trial drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA). However, NOV-205 has been approved by the Russian Federation for treatment of liver diseases including hepatitis C. Clinical studies in that country showed that subjects treated with NOV-205 alone had decreased indicators in the blood for the hepatitis C virus and for liver damage.
Detailed description
This Phase 1b trial aims to evaluate the pharmacokinetic profile of NOV-205, and in comparison to placebo, identify early signs of antiviral activity (with a quantitative reduction of >0.5 log10 in serum HCV RNA level (Elbeik, 2004)) and establish a safety profile of NOV-205 as monotherapy in subjects with chronic HCV who are non-responders to treatment with pegylated interferon plus ribavirin. This trial will also explore the effect of NOV-205 on serum biochemical markers of liver damage (e.g. alanine aminotransferase, ALT) as indications of biologic activity. Results of this trial will guide the design of future Phase 2 studies of NOV-205 in chronic hepatitis C subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A serum HCV RNA level of >100,000 IU/ml using a quantitative, branched-chain-DNA (bDNA)-based assay (lower limit of quantitation = ~650 IU/ml) or other equally sensitive quantitative methods.
- Infection with genotype 1 HCV
- Documented failure to respond to treatment (defined as a patient who did not achieve an early viral response (EVR) (≥2 log reduction in serum HCV RNA or undetectable HCV RNA after 12 weeks of treatment) OR is serum HCV RNA positive after 24 weeks of treatment with pegylated interferon plus ribavirin for hepatitis C.
- Women of childbearing potential willing to use two acceptable methods of birth control during trial participation or are sterile or post-menopausal (defined as not having a menstrual cycle for greater than two years)
- Sexually active male subjects are practicing acceptable methods of contraception during trial participation
Key exclusion criteria (6 listed)
- Clinical, laboratory, or histological evidence of liver cirrhosis
- Evidence of hepatic decompensation (presence of or a history of ascites, hepatic encephalopathy, variceal bleeding, or hepatocellular carcinoma)
- Co-infection with human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) (as determined by presence of hepatitis B surface antigen (HBsAg)
- Have received pegylated interferon and/or ribavirin within the 60 days prior to randomization
- Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol
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 |
|---|---|---|
| NOV-205 | Drug | – |
Primary outcome
To evaluate the pharmacokinetic profile of different dosing regimens of NOV-205.
To establish the safety profile of NOV-205 in comparison to that of placebo.
To compare changes in viral load after treatment with NOV-205 or placebo (as evidenced by a quantitative reduction of >0.5 log10 in serum HCV RNA levels by quantitative analysis as compared to the average of the screening and baseline values).
To evaluate the impact of NOV-205 on serum ALT and AST levels in comparison to that of placebo.
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 21 Dec 2007.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
Raymond Koff, MD principal investigator
University of Massachusetts, Worcester
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NOV-205 in people with Hepatitis C, run by Cellectar Biosciences, Inc..
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 7 inclusion and 6 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 21 Dec 2007. 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 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.
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 evaluate the pharmacokinetic profile of different dosing regimens of NOV-205.. The study lists 4 primary outcomes in all. 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 21 Dec 2007.