Chronic Hepatitis CPhase 1NCT00823862
Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
A Phase 1 study testing SD-101 and ribavirin in people with Chronic Hepatitis C, run by Dynavax Technologies Corporation at 5 sites in Poland.
Trial summary
To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101 alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- SD-101 and 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
- 34 participants
- Where
- 5 sitesPoland
- Study dates
- Oct 2008to Feb 2010
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed, written, informed consent
- Male or female subjects, 18 to 55 years of age.
- Subject must have chronic infection HCV, genotype 1.
- Serum HCV-RNA concentrations 100,000 IU/mL to 10,000,000 IU/mL
- No prior treatment for HCV.
- Must be negative for hepatitis B (HBV) and human immunodeficiency virus (HIV).
- Must be willing to use dual method of contraception (i.e., barrier and spermicide; birth control pills and barrier) during the study.
- No known hypersensitivity to study medication or to drugs chemically related to the study.
Who cannot join
- Prior treatment with IFN-based therapies and/or anti-viral therapies.
- Women with ongoing pregnancy or breast feeding and male partners of women who are pregnant.
- Reduced kidney function.
- Presence of concomitant liver diseases
- Signs or symptoms of hepatocellular carcinoma.
- Thyroid disease currently poorly controlled on prescribed medications.
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- History of hemoglobinopathy.
- Evidence of severe retinopathy.
- Other serious medical conditions, including human immunodeficiency virus, cancer (excluding non-melanoma skin cancer), or evidence of drug or alcohol abuse.
- Subjects with documented or presumed coronary artery disease, pulmonary disease, or cerebrovascular disease
- Clinically significant acute or chronic illnesses.
- History of severe psychiatric disease, especially depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites
Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika
Bydgoszcz, 85 - 030
Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie
Lublin, 20-089
Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych
Warsaw, 01-201
Wojewódzki Szpital Zakaźny
Warsaw, 01-201
EMC Instytut Medyczny S.A. Szpital Specjalistyczny z Przychodnią "EuroMediCare"
Wroclaw, 144-148
About this study
Official title: A Phase I, Randomized, Single-Blind, Placebo-Controlled Dose-Escalation Study of SD-101 to Assess the Safety, Pharmacodynamics, and Preliminary Evidence of Anti-Viral Effect in Subjects Diagnosed With Chronic Hepatitis C, Genotype 1
To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101 alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy.
- Conditions
- Chronic Hepatitis C
- Being tested
- SD-101, ribavirin
- Keywords
- HCV, Immunostimulatory sequence (ISS), TLR9 (toll-like receptor 9), interferon (IFN), 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.
SD-101Drug
Also called CpG Class C Immunostimulatory Sequence (ISS), TLR9 Agonist
Intramuscular (IM)
ribavirinDrug
oral, 2 times per day, for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Active (SD-101) | Experimental | SD-101 in cohorts of escalating doses Receives: Drug: SD-101; Drug: ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event timing, duration, and severity.
Measured: Between doses and up to 3 months after last dose
Secondary outcomes (2)
Biomarker analysis of blood sample
Measured: pre and 24 hour post dose
Viral load in blood sample
Measured: each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synteract, Inc., PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Janusz Cianciara, MD, Principal investigator, Warszawski Uniwersytet Medyczny
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823862
- Sponsor's protocol ID
- DV3-HCV-01
- Other IDs
- 2008-001708-22, 2008
- Status last verified
- Apr 2019
- First submitted
- 14 Jan 2009
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: 3/2017 no change to status in this Phase 1 study
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Single-Blind, Placebo-Controlled Dose-Escalation Study of SD-101 to Assess the Safety, Pharmacodynamics, and Preliminary Evidence of Anti-Viral Effect in Subjects Diagnosed With Chronic Hepatitis C, Genotype 1
- ClinicalTrials.gov ID
- NCT00823862
- Acronym / sponsor ID
- DV3-HCV-01
- Conditions
- Chronic Hepatitis C
- Keywords
- HCV, Immunostimulatory sequence (ISS), TLR9 (toll-like receptor 9), interferon (IFN), ribavirin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Synteract, Inc., PPD Development, LP
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 16 Jan 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.
To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101 alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active (SD-101) | Experimental | Drug: SD-101, Drug: ribavirinSD-101 in cohorts of escalating doses |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed, written, informed consent
- Male or female subjects, 18 to 55 years of age.
- Subject must have chronic infection HCV, genotype 1.
- Serum HCV-RNA concentrations 100,000 IU/mL to 10,000,000 IU/mL
- No prior treatment for HCV.
Key exclusion criteria (12 listed)
- Prior treatment with IFN-based therapies and/or anti-viral therapies.
- Women with ongoing pregnancy or breast feeding and male partners of women who are pregnant.
- Reduced kidney function.
- Presence of concomitant liver diseases
- Signs or symptoms of hepatocellular carcinoma.
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 |
|---|---|---|
| SD-101Also: CpG Class C Immunostimulatory Sequence (ISS), TLR9 AgonistIntramuscular (IM) | Drug | Active (SD-101) |
| ribavirinoral, 2 times per day, for 2 months | Drug | Active (SD-101) |
Primary outcome
Adverse event timing, duration, and severity.
Time frame: Between doses and up to 3 months after last dose
2 secondary outcomes
Biomarker analysis of blood sample
Time frame: pre and 24 hour post dose
Viral load in blood sample
Time frame: each visit
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 16 Apr 2019.
- Individual participant dataSharing planned: Undecided. 3/2017 no change to status in this Phase 1 study
Related trials for Chronic Hepatitis C
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RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
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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.
Janusz Cianciara, MD principal investigator
Warszawski Uniwersytet Medyczny
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SD-101 and ribavirin in people with Chronic Hepatitis C, run by Dynavax Technologies Corporation at 5 sites in Poland.
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 12 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland. 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 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?
Adverse event timing, duration, and severity. (time frame: Between doses and up to 3 months after last dose). 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 16 Apr 2019.