Hepatitis CPhase 1NCT01567540
A Pilot Study Evaluating Safety of Sitagliptin Combined With Peg-IFN Alfa-2a + Ribavirin in Chronic Hepatitis C Patients
A Phase 1 study testing Sitagliptin in people with Hepatitis C, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in France.
Trial summary
Hepatitis C infection is a major public health problem with nearly 175 million infected individuals worldwide. Although cure is possible, only 20-40% of patients spontaneously resolve infection and 40-80% of chronically infected patients (numbers vary depending on viral genotype) that receive… 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?
- Sitagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 4 sitesFrance
- Study dates
- Mar 2013to Jan 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years
- For women, effective contraception during the trial and a negative pregnancy test (urine) before enrollment
- Patients naïve to prior hepatitis C treatment
- Confirmed HCV infection, based on the presence of HCV antibodies and plasma viremia allowing a measure of the circulating viral load
- Infection with HCV genotype 1 or 4
- Intent of treatment Alfa2 pegylated IFN-/ ribavirin
Who cannot join
- HBV Infection
- HIV Infection
- Severe anemia (Hb <7-8 g / dl)
- Renal failure (creatinine clearance <60 ml / min)
- Taking digoxin within 6 months of starting treatment.
- Taking immunosuppressants within 6 months of starting treatment
Show all 11Show fewer
- History of serious hypersensitivity reaction (such as anaphylactic shock or angioedema) to sitagliptin
- Patients with type I and II diabetes
- Pregnancy or absence of effective contraception
- A person deprived of liberty by judicial or administrative decision
- Living conditions-suggesting an inability to track all scheduled visits by the protocol
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Hospitalier Victor Dupuy
Argenteuil, 95100
Centre Hospitalier Intercommunal Créteil
Créteil, 94010
Henri Mondor Hospital
Créteil, 94010
Cochin Hospital
Paris, 75014
About this study
Official title: A Pilot Study to Evaluate the Clinical and Biological Tolerance of Sitagliptin With Pegylated Interferon alfa2a Plus Ribavirin Combination Therapy in Chronic Hepatitis C Patients
Hepatitis C infection is a major public health problem with nearly 175 million infected individuals worldwide. Although cure is possible, only 20-40% of patients spontaneously resolve infection and 40-80% of chronically infected patients (numbers vary depending on viral genotype) that receive pegylated-interferon-alfa2a/ribavirin therapy clear the virus and are sustained virologic responders (SVR). Still for many, the virus manages to circumvent natural immunity and current therapeutic strategies, resulting in significant morbidity and mortality.
To better define the distinct clinical outcomes of HCV infection many investigators have performed candidate molecules screens or transcriptional profiling in order to identify correlates of viral clearance. One molecule that has gained significant attention is CXCL10 (also known as interferon-gamma induced protein-10 or IP-10) as an important negative prognostic biomarker. Given that CXCL10 is produced by hepatocytes and mediates chemo-attraction of activated lymphocytes expressing the CXCL10-receptor, CXCR3, it is counter-intuitive as to why this chemokine correlates with therapeutic non-responsiveness.
The investigators hypothesized and have now demonstrated that CXCL10 is being cleaved in situ, resulting in the generation of an antagonist form of the chemokine. Based on the use of specific inhibitors, the investigators now propose to test whether protection of the agonist form of CXCL10 will increase responsiveness to peg-IFN-alfa2 / ribavirin therapy. This can be achieved using DPPIV inhibitors, targeting the enzyme responsible for N-terminal truncation of CXCL10. If safety is confirmed, the efficacy of DPPIV-inhibition in HCV patients will be tested in future trials that examine potential clearance benefits.
- Conditions
- Hepatitis C
- Being tested
- Sitagliptin
- Keywords
- Chronic Hepatitis C, Interferon protein 10, Chemokine gradients, Sitagliptin
- 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.
SitagliptinDrug
100 mg Sitagliptin daily for 15 weeks
| Study group | Role | What they receive |
|---|---|---|
| DPPIV Inhibition | Experimental | The study includes an initial phase of 3 weeks with administration of sitagliptin (100 mg/d) as monotherapy, followed immediately by 12 weeks of triple therapy (sitagliptin 100 mg/d combined with peg-IFN alfa-2a and ribavirin). Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Number of adverse events, Toxicity grade > 3)
Measured: After Day 1 until the end of the trial, i.e. a duration of 15 weeks for each patient
Secondary outcomes (5)
Change in Viral Load as compared to baseline
Measured: week 1, 2, 3 of sitagliptin monotherapy; week 2, 4, 12 of triple therapy
Metabolic studies: Oral glucose tolerance will be assessed
Measured: baseline, week 1 of sitagliptin monotherapy; week 2 of triple therapy
Immunologic study
Monitoring the short and long form of IP-10 as compared to the total plasma concentration (three distinct ELISA assays).
Measured: baseline, week 1 and 3 of sitagliptin monotherapy; week 1, 2, 4, 12 of triple therapy
Immunologic study
Plasma concentration and activity of DPPIV (measured using an ELISA and a luciferase-based bioassay, respectively).
Measured: baseline; week 1 and 3 of sitagliptin monotherapy; week 1, 2, 4, 12 of triple therapy
Immunologic study
Frequency of CXCR3+ cells in circulation (monitored by FACS).
Measured: baseline, week 1 and 3 of sitagliptin monotherapy; week 1, 2, 4, 12 of triple therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: New treatments available, which prevents additional recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Matthew L. ALBERT, MD, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567540
- Sponsor's protocol ID
- C10-54
- Other IDs
- 2011-000823-34
- Status last verified
- Jan 2014
- First submitted
- 2 Mar 2012
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Decalf J, Tarbell KV, Casrouge A, Price JD, Linder G, Mottez E, Sultanik P, Mallet V, Pol S, Duffy D, Albert ML. Inhibition of DPP4 activity in humans establishes its in vivo role in CXCL10 post-translational modification: prospective placebo-controlled clinical studies. EMBO Mol Med. 2016 Jun 1;8(6):679-83. doi: 10.15252/emmm.201506145. Print 2016 Jun.
PubMed 27137491
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Clinical and Biological Tolerance of Sitagliptin With Pegylated Interferon alfa2a Plus Ribavirin Combination Therapy in Chronic Hepatitis C Patients
- ClinicalTrials.gov ID
- NCT01567540
- Acronym / sponsor ID
- C10-54
- Conditions
- Hepatitis C
- Keywords
- Chronic Hepatitis C, Interferon protein 10, Chemokine gradients, Sitagliptin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New treatments available, which prevents additional recruitment.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Mar 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.
Hepatitis C infection is a major public health problem with nearly 175 million infected individuals worldwide. Although cure is possible, only 20-40% of patients spontaneously resolve infection and 40-80% of chronically infected patients (numbers vary depending on viral genotype) that receive pegylated-interferon-alfa2a/ribavirin therapy clear the virus and are sustained virologic responders (SVR). Still for many, the virus manages to circumvent natural immunity and current therapeutic strategies, resulting in significant morbidity and mortality.
To better define the distinct clinical outcomes of HCV infection many investigators have performed candidate molecules screens or transcriptional profiling in order to identify correlates of viral clearance. One molecule that has gained significant attention is CXCL10 (also known as interferon-gamma induced protein-10 or IP-10) as an important negative prognostic biomarker. Given that CXCL10 is produced by hepatocytes and mediates chemo-attraction of activated lymphocytes expressing the CXCL10-receptor, CXCR3, it is counter-intuitive as to why this chemokine correlates with therapeutic non-responsiveness.
The investigators hypothesized and have now demonstrated that CXCL10 is being cleaved in situ, resulting in the generation of an antagonist form of the chemokine. Based on the use of specific inhibitors, the investigators now propose to test whether protection of the agonist form of CXCL10 will increase responsiveness to peg-IFN-alfa2 / ribavirin therapy. This can be achieved using DPPIV inhibitors, targeting the enzyme responsible for N-terminal truncation of CXCL10. If safety is confirmed, the efficacy of DPPIV-inhibition in HCV patients will be tested in future trials that examine potential clearance benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DPPIV Inhibition | Experimental | Drug: SitagliptinThe study includes an initial phase of 3 weeks with administration of sitagliptin (100 mg/d) as monotherapy, followed immediately by 12 weeks of triple therapy (sitagliptin 100 mg/d combined with peg-IFN alfa-2a and ribavirin). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 70 years
- For women, effective contraception during the trial and a negative pregnancy test (urine) before enrollment
- Patients naïve to prior hepatitis C treatment
- Confirmed HCV infection, based on the presence of HCV antibodies and plasma viremia allowing a measure of the circulating viral load
- Infection with HCV genotype 1 or 4
Key exclusion criteria (11 listed)
- HBV Infection
- HIV Infection
- Severe anemia (Hb <7-8 g / dl)
- Renal failure (creatinine clearance <60 ml / min)
- Taking digoxin within 6 months of starting treatment.
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 |
|---|---|---|
| Sitagliptin100 mg Sitagliptin daily for 15 weeks | Drug | DPPIV Inhibition |
Primary outcome
Safety (Number of adverse events, Toxicity grade > 3)
Time frame: After Day 1 until the end of the trial, i.e. a duration of 15 weeks for each patient
5 secondary outcomes
Change in Viral Load as compared to baseline
Time frame: week 1, 2, 3 of sitagliptin monotherapy; week 2, 4, 12 of triple therapy
Metabolic studies: Oral glucose tolerance will be assessed
Time frame: baseline, week 1 of sitagliptin monotherapy; week 2 of triple therapy
Immunologic study
Time frame: baseline, week 1 and 3 of sitagliptin monotherapy; week 1, 2, 4, 12 of triple therapy
Immunologic study
Time frame: baseline; week 1 and 3 of sitagliptin monotherapy; week 1, 2, 4, 12 of triple therapy
Immunologic study
Time frame: baseline, week 1 and 3 of sitagliptin monotherapy; week 1, 2, 4, 12 of triple therapy.
Results and safety
The study was stopped early (reason given: New treatments available, which prevents additional recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Results publication: PubMed 27137491Decalf J, Tarbell KV, Casrouge A, Price JD, Linder G, Mottez E, Sultanik P, Mallet V, Pol S, Duffy D, Albert ML. Inhibition of DPP4 activity in humans establishes its in vivo role in CXCL10 post-translational modification: prospective placebo-controlled clinical studies. EMBO Mol Med. 2016 Jun 1;8(6):679-83. doi: 10.15252/emmm.201506145. Print 2016 Jun.
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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.
Matthew L. ALBERT, MD, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
4 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 Sitagliptin in people with Hepatitis C, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in France.
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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 was stopped early (reason given: New treatments available, which prevents additional recruitment.). 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?
Safety (Number of adverse events, Toxicity grade > 3) (time frame: After Day 1 until the end of the trial, i.e. a duration of 15 weeks for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01567540, which also lists 1 linked publication.
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 7 Oct 2026.