Hepatitis CPhase 2NCT01727934
Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C
A Phase 2 study testing Miravirsen sodium in people with Hepatitis C, run by Santaris Pharma A/S at 1 site in Puerto Rico.
Trial summary
The purpose of this open-label study is to assess the safety, antiviral activity, and pharmacokinetics of 9 subcutaneous injections of miravirsen monotherapy (5 weekly doses over 5 weeks, followed by a further 4 doses once every other week over 7 weeks) over a total of 12 weeks of treatment. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Miravirsen sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Nov 2012to Apr 2014
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic hepatitis C
- HCV genotype 1
- BMI 18-38 kg/m2
- Null responder to pegylated interferon alpha and ribavirin
Who cannot join
- Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Significant liver disease in addition to hepatitis C
- Decompensated liver disease medical history or current clinical features
- Histologic evidence of hepatic cirrhosis
- Concurrent clinically significant medical diagnosis (other than CHC)
- Concurrent social conditions (e.g. drugs of abuse, alcohol excess, poor living accommodation)
Show all 9Show fewer
- Clinically significant illness within 30 days preceding entry into the study
- Participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication
- History of clinically significant allergic drug reactions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection
The purpose of this open-label study is to assess the safety, antiviral activity, and pharmacokinetics of 9 subcutaneous injections of miravirsen monotherapy (5 weekly doses over 5 weeks, followed by a further 4 doses once every other week over 7 weeks) over a total of 12 weeks of treatment. The subjects enrolled in this study are chronically infected with HCV genotype 1 and are null responders to treatment with peg IFNα/RBV therapy.
- Conditions
- Hepatitis C
- Being tested
- Miravirsen sodium
- Keywords
- Antisense, miR-122 antagonist, host factor, Chronic hepatitis C, Hepatitis C
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miravirsen sodiumDrug
Also called SPC3649
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Miravirsen sodium | Experimental | Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg then 4 every other week doses at 5 mg/kg. Receives: Drug: Miravirsen sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with sustained virological response 24 weeks after the end of therapy.
Measured: 36 weeks
Secondary outcomes (5)
The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy.
Measured: 60 weeks
The proportion of subjects with undetectable HCV RNA levels at the end of treatment.
Measured: 12 weeks
Change in HCV RNA levels from baseline throughout the study.
Measured: 60 weeks
The proportion of subjects who experience virological failure throughout the study.
Measured: 60 weeks
Safety will be assessed by evaluation of adverse events, physical examinations, vital signs, 12-lead ECGs, and laboratory assessments (clinical chemistry, hematology, urinalysis).
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2014 (estimated)
- Study completionApr 2014 (estimated)
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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santaris Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maribel Rodriguez-Torres, MD, Principal investigator, Fundacion de Investgacion de Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727934
- Sponsor's protocol ID
- SPC3649-207
- Status last verified
- Jan 2014
- First submitted
- 12 Nov 2012
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection
- ClinicalTrials.gov ID
- NCT01727934
- Acronym / sponsor ID
- SPC3649-207
- Conditions
- Hepatitis C
- Keywords
- Antisense, miR-122 antagonist, host factor, Chronic hepatitis C, Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Santaris Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 16 Nov 2012 (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 open-label study is to assess the safety, antiviral activity, and pharmacokinetics of 9 subcutaneous injections of miravirsen monotherapy (5 weekly doses over 5 weeks, followed by a further 4 doses once every other week over 7 weeks) over a total of 12 weeks of treatment. The subjects enrolled in this study are chronically infected with HCV genotype 1 and are null responders to treatment with peg IFNα/RBV therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Miravirsen sodium | Experimental | Drug: Miravirsen sodiumMiravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg then 4 every other week doses at 5 mg/kg. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of chronic hepatitis C
- HCV genotype 1
- BMI 18-38 kg/m2
- Null responder to pegylated interferon alpha and ribavirin
Key exclusion criteria (9 listed)
- Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Significant liver disease in addition to hepatitis C
- Decompensated liver disease medical history or current clinical features
- Histologic evidence of hepatic cirrhosis
- Concurrent clinically significant medical diagnosis (other than CHC)
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 |
|---|---|---|
| Miravirsen sodiumAlso: SPC3649Subcutaneous injection | Drug | Miravirsen sodium |
Primary outcome
The proportion of subjects with sustained virological response 24 weeks after the end of therapy.
Time frame: 36 weeks
5 secondary outcomes
The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy.
Time frame: 60 weeks
The proportion of subjects with undetectable HCV RNA levels at the end of treatment.
Time frame: 12 weeks
Change in HCV RNA levels from baseline throughout the study.
Time frame: 60 weeks
The proportion of subjects who experience virological failure throughout the study.
Time frame: 60 weeks
Safety will be assessed by evaluation of adverse events, physical examinations, vital signs, 12-lead ECGs, and laboratory assessments (clinical chemistry, hematology, urinalysis).
Time frame: 60 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
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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.
Maribel Rodriguez-Torres, MD principal investigator
Fundacion de Investgacion de Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Miravirsen sodium in people with Hepatitis C, run by Santaris Pharma A/S at 1 site in Puerto Rico.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Jan 2014. 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 Puerto Rico. 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?
Results are not available in the source record.
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?
The proportion of subjects with sustained virological response 24 weeks after the end of therapy. (time frame: 36 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 6 Jan 2014.