Hepatitis C, ChronicPhase 2NCT01872936
Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection
A Phase 2 study testing Miravirsen, Telaprevir and Ribavirin in people with Hepatitis C, Chronic, run by Santaris Pharma A/S at 3 sites in 2 countries.
Trial summary
The purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Miravirsen, Telaprevir and Ribavirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2013to Jan 2015
- 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
- Diagnosis of chronic hepatitis C genotype 1 infection
- BMI 18 and 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
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203
Research Specialists of Texas
Houston, Texas, 77030
About this study
Official title: Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Genotype 1 Infection
The purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Miravirsen, Telaprevir, Ribavirin
- 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.
MiravirsenDrug
Also called SPC3649, Miravirsen sodium
TelaprevirDrug
Also called Incivek
RibavirinDrug
Also called Copegus
| Study group | Role | What they receive |
|---|---|---|
| Miravirsen every other week dosing | Other | Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg, then 6 every other week doses at 5 mg/kg in combination with telaprevir and ribavirin. Receives: Drug: Miravirsen; Drug: Telaprevir; Drug: Ribavirin |
| Miravirsen monthly dosing | Other | Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg, then 3 monthly doses at 7 mg/kg in combination with telaprevir and ribavirin. Receives: Drug: Miravirsen; Drug: Telaprevir; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.
Measured: 42 weeks
Secondary outcomes (4)
The proportion of subjects with undetectable HCV RNA levels at end of treatment.
Measured: 18 weeks
The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy.
Measured: 66 Weeks
Change in HCV RNA levels from baseline throughout the study.
Measured: 66 Weeks
The proportion of subjects who experience virological failure throughout the study.
Measured: 66 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santaris Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Hodges, MD, Study director, Santaris Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872936
- Sponsor's protocol ID
- SPC3649-205
- Status last verified
- Nov 2014
- First submitted
- 3 Jun 2013
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Genotype 1 Infection
- ClinicalTrials.gov ID
- NCT01872936
- Acronym / sponsor ID
- SPC3649-205
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Santaris Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 7 Jun 2013 (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, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miravirsen every other week dosing | Other | Drug: Miravirsen, Drug: Telaprevir, Drug: RibavirinMiravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg, then 6 every other week doses at 5 mg/kg in combination with telaprevir and ribavirin. |
| Miravirsen monthly dosing | Other | Drug: Miravirsen, Drug: Telaprevir, Drug: RibavirinMiravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg, then 3 monthly doses at 7 mg/kg in combination with telaprevir and ribavirin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of chronic hepatitis C genotype 1 infection
- BMI 18 and 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 |
|---|---|---|
| MiravirsenAlso: SPC3649, Miravirsen sodium | Drug | Miravirsen every other week dosing, Miravirsen monthly dosing |
| TelaprevirAlso: Incivek | Drug | Miravirsen every other week dosing, Miravirsen monthly dosing |
| RibavirinAlso: Copegus | Drug | Miravirsen every other week dosing, Miravirsen monthly dosing |
Primary outcome
The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.
Time frame: 42 weeks
4 secondary outcomes
The proportion of subjects with undetectable HCV RNA levels at end of treatment.
Time frame: 18 weeks
The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy.
Time frame: 66 Weeks
Change in HCV RNA levels from baseline throughout the study.
Time frame: 66 Weeks
The proportion of subjects who experience virological failure throughout the study.
Time frame: 66 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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.
Michael Hodges, MD study director
Santaris Pharma A/S
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Miravirsen, Telaprevir and Ribavirin in people with Hepatitis C, Chronic, run by Santaris Pharma A/S at 3 sites in 2 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 3 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 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, 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 a Sustained Virological Response at 24 weeks after the end of therapy. (time frame: 42 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 18 Nov 2014.