Hepatitis CPhase 2NOV-205NCT01058512
A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy
A Phase 2 study testing NOV-205 in people with Hepatitis C, run by Cellectar Biosciences, Inc. at 6 sites in United States.
Trial summary
The purpose of this research study is to find out the effect of the investigational drug NOV-205 on the level of hepatitis C virus in the blood and whether NOV-205 is well-tolerated at different doses when taken by subjects with hepatitis C. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- NOV-205
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2010to Dec 2010
- 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 70 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
- Adequate laboratory parameters
- 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 enrollment
- Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol
- Pregnant female or nursing mother
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304
MetroWest Medical Center
Framingham, Massachusetts, 01702
Borland-Grooover Clinic
Jacksonville, Florida, 32256
Venture Research Institute, LLC
Miami, Florida, 33162
Orlando Immunology Center
Orlando, Florida, 32803
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: A Phase 2 Trial of NOV-205 in Chronic Viral Hepatitis C Patients (Genotype 1) Who Have Failed Treatment With Pegylated Interferon Plus Ribavirin
The purpose of this research study is to find out the effect of the investigational drug NOV-205 on the level of hepatitis C virus in the blood and whether NOV-205 is well-tolerated at different doses when taken by subjects with hepatitis C.
- Conditions
- Hepatitis C
- Being tested
- NOV-205
- Keywords
- hepatitis C, chronic HCV, viral HCV, 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
There will be 4 treatment Groups with 10 patients in each group:
- Group A: 30 mg NOV-205 daily subcutaneous administration for 49 days
- Group B: 30 mg NOV-205 daily subcutaneous administration for 98 days
- Group C: 60 mg NOV-205 daily subcutaneous administration for 49 days
- Group D: 60 mg NOV-205 daily subcutaneous administration for 98 days
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | single-arm study Receives: Drug: NOV-205 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate changes in viral load
Measured: 16 months
To evaluate changes in serum ALT and AST levels
Measured: 16 months
To evaluate the durability of any changes in viral load and serum ALT and AST
Measured: 16 months
To establish the safety profile of NOV-205
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionDec 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellectar Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond Koff, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058512
- Sponsor's protocol ID
- NOV205-C201
- Acronym
- NOV-205
- Status last verified
- Jul 2022
- First submitted
- 26 Jan 2010
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of NOV-205 in Chronic Viral Hepatitis C Patients (Genotype 1) Who Have Failed Treatment With Pegylated Interferon Plus Ribavirin
- ClinicalTrials.gov ID
- NCT01058512
- Acronym / sponsor ID
- NOV-205 / NOV205-C201
- Conditions
- Hepatitis C
- Keywords
- hepatitis C, chronic HCV, viral HCV, genotype 1, failed treatment with pegylated interferon plus ribavirin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cellectar Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Jan 2010 (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 study is to find out the effect of the investigational drug NOV-205 on the level of hepatitis C virus in the blood and whether NOV-205 is well-tolerated at different doses when taken by subjects with hepatitis C.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Drug: NOV-205single-arm study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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
- Adequate laboratory parameters
- 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)
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 enrollment
- 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-205There will be 4 treatment Groups with 10 patients in each group: * Group A: 30 mg NOV-205 daily subcutaneous administration for 49 days * Group B: 30 mg NOV-205 daily subcutaneous administration for 98 days * Group C: 60 mg NOV-205 daily subcutaneous administration for 49 days * Group D: 60 mg NOV-205 daily subcutaneous administration for 98 days | Drug | Single |
Primary outcome
To evaluate changes in viral load
Time frame: 16 months
To evaluate changes in serum ALT and AST levels
Time frame: 16 months
To evaluate the durability of any changes in viral load and serum ALT and AST
Time frame: 16 months
To establish the safety profile of NOV-205
Time frame: 16 months
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 25 Jul 2022.
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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.
Raymond Koff, MD principal investigator
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NOV-205 in people with Hepatitis C, run by Cellectar Biosciences, Inc. at 6 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 8 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 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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?
To evaluate changes in viral load (time frame: 16 months). 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 25 Jul 2022.