Chronic Hepatitis CETIMNCT01641094
Effect of Teleprevir in Triple Therapy on Intrahepatic Immunological Mechanisms
An observational study of Chronic Hepatitis C, run by Foundation for Liver Research at 2 sites in Netherlands.
Trial summary
Chronic hepatitis C infection (HCV) is a disease that affects worldwide about 170 million people. The previous standard of care therapy of chronic HCV patients consists of pegylated-IFN-α combined with ribavirin, and results in sustained clearance of HCV-RNA in only about 50% of the HCV genotype 1 infected patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- May 2012to Dec 2014
- Phase
- Observational
- 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
Study population: Patients with chronic hepatitis C, genotype 1
Who may be able to join
- Patients between 18 and 70 years of age, with a chronic hepatitis C - genotype 1 infection
- Patients are naive, non-responders or relapsers to previous treatment with peginterferon or conventional interferon plus ribavirin combination therapy
- High viral load (>400,000 IU/ml)
- Indication for antiviral therapy of hepatitis C according to current clinical guidelines
Who cannot join
- Decompensated cirrhosis (Child-Pugh Grade B or C)
- Hepatic imaging (ultrasound, CT or MRI) with the evidence of hepatocellular carcinoma.
- Females who are pregnant or breast-feeding
- History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigators, unsuitable for the study
- Co-infections with human immunodeficiency virus (HIV) or Hepatitis B virus (HBV)
- Presence of contra-indications for antiviral therapy with telaprevir:
Show all 22Show fewer
- Telaprevir is contraindicated when combined with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Telaprevir in contraindicated when combined with drugs that strongly induce CYP3A and thus may lead to lower exposure and loss of efficacy of Telaprevir. The contraindicated medications include the following:
- Alfuzosin
- Rifampicin
- Dihydroergotamine, ergonovine, ergotamine, methylergonovine
- Cisapride
- St John's wort
- Atorvastatin, lovastatin, simvastatin
- Pimozide
- Sildenafil or tadalafil
- Triazolam
- Presence of contra-indications for antiviral therapy with peginterferon or ribavirin
- Severe psychiatric disorder, such as major psychoses, suicidal ideation, suicidal attempt and/or manifest depression.
- Visual symptoms related to retinal abnormalities
- Pregnancy, breast-feeding or inadequate contraception
- Thalassemia, spherocytosis
- Interfering substance abuse, such as high alcohol intake (indicator: 28 drinks/ week)
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Reinier de Graaf Ziekenhuis
Delft, South Holland
Erasmus Medical Center
Rotterdam, 3015 CE
About this study
Official title: Effect of Telaprevir in Triple Therapy on Intrahepatic Immunological Mechanisms.
Chronic hepatitis C infection (HCV) is a disease that affects worldwide about 170 million people. The previous standard of care therapy of chronic HCV patients consists of pegylated-IFN-α combined with ribavirin, and results in sustained clearance of HCV-RNA in only about 50% of the HCV genotype 1 infected patients. Telaprevir, a NS3A-4A inhibitor, has previously proven to offer therapeutic options to previous non-responders to the standard of care. Although, not all chronic HCV patients benefit from telaprevir and it is still not known why certain patients are also non-responsive to this triple therapy. In this study we try to understand why certain patients are also non-responsive to telaprevir, how triple therapy modulates the responsiveness to IFN-α and what the immunological consequences are of treatment with telaprevir, either directly or as a result of telaprevir-induced reduction of HCV-RNA levels.
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Liver, Immunology, Genotype 1, Treatment, Chronic, RNA Virus Infections, Ribavirin, Peginterferon alfa-2a, Protease Inhibitors, Telaprevir
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Bronchiolitis Obliterans Syndrome, RNA Virus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine functionality of immune cells in the liver and blood in chronic HCV patients before, during and after treatment with telaprevir, pegylated-IFN-a and ribavirin
By looking at T cells, NK cells and monocytes during triple therapy, as well intrahepatic as in peripheral blood, we try to better understand why some patients respond and others do not respond to therapy.
Measured: 24 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2014
- Study completionDec 2014
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Liver Research
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag B.V.
- Responsible party
- Sponsor
- Investigators
- A. Boonstra, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641094
- Sponsor's protocol ID
- ETIM
- Acronym
- ETIM
- Status last verified
- Mar 2015
- First submitted
- 12 Jul 2012
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telaprevir in Triple Therapy on Intrahepatic Immunological Mechanisms.
- ClinicalTrials.gov ID
- NCT01641094
- Acronym / sponsor ID
- ETIM / ETIM
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Liver, Immunology, Genotype 1, Treatment, Chronic, RNA Virus Infections, Ribavirin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Foundation for Liver ResearchUniversity, hospital or other
- Collaborators
- Janssen-Cilag B.V.
- Study start
- May 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Jul 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.
Chronic hepatitis C infection (HCV) is a disease that affects worldwide about 170 million people. The previous standard of care therapy of chronic HCV patients consists of pegylated-IFN-α combined with ribavirin, and results in sustained clearance of HCV-RNA in only about 50% of the HCV genotype 1 infected patients. Telaprevir, a NS3A-4A inhibitor, has previously proven to offer therapeutic options to previous non-responders to the standard of care. Although, not all chronic HCV patients benefit from telaprevir and it is still not known why certain patients are also non-responsive to this triple therapy. In this study we try to understand why certain patients are also non-responsive to telaprevir, how triple therapy modulates the responsiveness to IFN-α and what the immunological consequences are of treatment with telaprevir, either directly or as a result of telaprevir-induced reduction of HCV-RNA levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis C, genotype 1
Key inclusion criteria (4 listed)
- Patients between 18 and 70 years of age, with a chronic hepatitis C - genotype 1 infection
- Patients are naive, non-responders or relapsers to previous treatment with peginterferon or conventional interferon plus ribavirin combination therapy
- High viral load (>400,000 IU/ml)
- Indication for antiviral therapy of hepatitis C according to current clinical guidelines
Key exclusion criteria (22 listed)
- Decompensated cirrhosis (Child-Pugh Grade B or C)
- Hepatic imaging (ultrasound, CT or MRI) with the evidence of hepatocellular carcinoma.
- Females who are pregnant or breast-feeding
- History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigators, unsuitable for the study
- Co-infections with human immunodeficiency virus (HIV) or Hepatitis B virus (HBV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine functionality of immune cells in the liver and blood in chronic HCV patients before, during and after treatment with telaprevir, pegylated-IFN-a and ribavirin
Time frame: 24 week follow-up
By looking at T cells, NK cells and monocytes during triple therapy, as well intrahepatic as in peripheral blood, we try to better understand why some patients respond and others do not respond to therapy.
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 11 Mar 2015.
- Website of the Department of Gastroenterology \& Hepatology - Erasmus Medical CenterLink provided by the sponsor.
- Website of the Erasmus Medical Center RotterdamLink provided by the sponsor.
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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.
A. Boonstra, PhD principal investigator
Erasmus Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C, run by Foundation for Liver Research at 2 sites in Netherlands.
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 22 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 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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.
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?
Determine functionality of immune cells in the liver and blood in chronic HCV patients before, during and after treatment with telaprevir, pegylated-IFN-a and ribavirin (time frame: 24 week follow-up). 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 11 Mar 2015.