Chronic Hepatitis, C VirusPhase 4NCT02950870
Efficacy Study to Evaluate the Effect of New Antiviral Drugs on HCV Infection.
A Phase 4 study testing Ombitasvir-Paritaprevir-Ritonavir, Dasabuvir and Ribavirin in people with Chronic Hepatitis, C Virus, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
The purpose of this study is to determinate the AMH levels before and after antiviral therapy with Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in comparison with age-matched HCV-positive women not undergoing antiviral treatment. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Chronic Hepatitis, C Virus
- What is being tested?
- Ombitasvir-Paritaprevir-Ritonavir, Dasabuvir and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2016to Dec 2019
- Phase
- Phase 4
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female between 18 and 35 years of age at the time of Screening
- Childbearing potential and sexually active with male partner(s) currently using at least one effective method of birth control at the time of screening and two effective methods of birth control while receiving study drugs, starting with Study Day 1 and for 7 months after stopping study drug.
- Females must have negative results for pregnancy tests
- Chronic HCV-infection prior to study enrollment
- Screening laboratory result indicating HCV GT 1b or GT 1a or GT 4 infection.
- Must be able to voluntarily sign and date an informed consent form
- Liver biopsy within 24 months prior to or during screening demonstrating a Metavir score of 2 or less or an Ishak score of 3 or less or Screening FibroScan® result of ≤ 9.6 kPa;
Who cannot join
- Women who are pregnant or breastfeeding
- Positive test result for HBsAg and HIV Ab
- Recent history of drug or alcohol
- HCV genotype performed during screening indicates more than 1 subtype or co-infection with any other genotype.
- Use of medications contraindicated
- Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inducers of cytochrome P450 2C8 (CYP2C8) or strong inhibitors of CYP2C8
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- History of solid organ transplant.
- Confirmed presence of hepatocellular carcinoma
- Current use of any investigational or commercially available anti-HCV agents
- Screening laboratory analyses showing any of the following abnormal laboratory results
Trial locations and contacts
1 site in 1 country.
Italy1 site
Gastroenterology Unit
Modena, Modena, 41124
Erica Villa, Prof., +390594225308, erica.villa@unimore.it
VERONICA BERNABUCCI, MD, +390594223109, veronica.bernabucci@gmail.com
About this study
Official title: An Open-Label Study to Evaluate Long-Term Outcomes With Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Fertile Women With Genotype 1 and 4 Chronic Hepatitis C Virus (HCV) Infection
The purpose of this study is to determinate the AMH levels before and after antiviral therapy with Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in comparison with age-matched HCV-positive women not undergoing antiviral treatment.
Read the detailed description
The study is interventional, controlled randomized (block 2:1 case: controls) in open label.
- Conditions
- Chronic Hepatitis, C Virus
- Being tested
- Ombitasvir-Paritaprevir-Ritonavir, Dasabuvir, 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.
Ombitasvir-Paritaprevir-RitonavirDrug
Also called Viekirax
The patient will be treated daily with Ombitasvir-Paritaprevir-Ritonavir 25/150/100 mg total dose
DasabuvirDrug
Also called Exvieria
The patient will be treated daily with Dasubavir 500 mg total dose
RibavirinDrug
Also called RBV
Patients will be treated with ribavirin if necessary.
| Study group | Role | What they receive |
|---|---|---|
| group treated | Experimental | this group will be treated with Ombitasvir-Paritaprevir-Ritonavir (12,5 mg/75 mg/50 mg) and Dasabuvir ( 250 mg) with or without Ribavirina every day , for 12 weeks. Receives: Drug: Ombitasvir-Paritaprevir-Ritonavir; Drug: Dasabuvir; Drug: Ribavirin |
| group untreated | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modification of AMH levels
The primary outcome is to evaluate the modification of AMH levels before and after successful antiviral therapy in comparison with age-matched HCV-positive women not undergoing antiviral treatment is the primary endpoint
Measured: 48 weeks post treatment
Secondary outcomes (3)
Modification of AMH levels
Modification of AMH levels before and after successful antiviral therapy
Measured: 144 weeks
Modification of the Estradiol (E2) levels
Modification of the Estradiol (E2) levels before and after successful antiviral therapy in comparison with age-matched HCV-positive women not undergoing antiviral treatment is the primary endpoint
Measured: 144 weeks
Percentage of participants experiencing miscarriage
Percentage of participants experiencing miscarriage during 3 years observation post-therapy.
Measured: 144 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis, C VirusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Facchinetti Fabio, University of Modena and Reggio Emilia
- Investigators
- ERICA VILLA, Prof., Principal investigator, Gastroenterology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950870
- Sponsor's protocol ID
- HCV_AMH_16
- Status last verified
- Oct 2016
- First submitted
- 26 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate Long-Term Outcomes With Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Fertile Women With Genotype 1 and 4 Chronic Hepatitis C Virus (HCV) Infection
- ClinicalTrials.gov ID
- NCT02950870
- Acronym / sponsor ID
- HCV_AMH_16
- Conditions
- Chronic Hepatitis, C Virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Nov 2016 (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 study is to determinate the AMH levels before and after antiviral therapy with Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in comparison with age-matched HCV-positive women not undergoing antiviral treatment.
Detailed description
The study is interventional, controlled randomized (block 2:1 case: controls) in open label.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group treated | Experimental | Drug: Ombitasvir-Paritaprevir-Ritonavir, Drug: Dasabuvir, Drug: Ribavirinthis group will be treated with Ombitasvir-Paritaprevir-Ritonavir (12,5 mg/75 mg/50 mg) and Dasabuvir ( 250 mg) with or without Ribavirina every day , for 12 weeks. |
| group untreated | No intervention | –Control group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female between 18 and 35 years of age at the time of Screening
- Childbearing potential and sexually active with male partner(s) currently using at least one effective method of birth control at the time of screening and two effective methods of birth control while receiving study drugs, starting with Study Day 1 and for 7 months after stopping study drug.
- Females must have negative results for pregnancy tests
- Chronic HCV-infection prior to study enrollment
- Screening laboratory result indicating HCV GT 1b or GT 1a or GT 4 infection.
Key exclusion criteria (10 listed)
- Women who are pregnant or breastfeeding
- Positive test result for HBsAg and HIV Ab
- Recent history of drug or alcohol
- HCV genotype performed during screening indicates more than 1 subtype or co-infection with any other genotype.
- Use of medications contraindicated
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 |
|---|---|---|
| Ombitasvir-Paritaprevir-RitonavirAlso: ViekiraxThe patient will be treated daily with Ombitasvir-Paritaprevir-Ritonavir 25/150/100 mg total dose | Drug | group treated |
| DasabuvirAlso: ExvieriaThe patient will be treated daily with Dasubavir 500 mg total dose | Drug | group treated |
| RibavirinAlso: RBVPatients will be treated with ribavirin if necessary. | Drug | group treated |
Primary outcome
The modification of AMH levels
Time frame: 48 weeks post treatment
The primary outcome is to evaluate the modification of AMH levels before and after successful antiviral therapy in comparison with age-matched HCV-positive women not undergoing antiviral treatment is the primary endpoint
3 secondary outcomes
Modification of AMH levels
Time frame: 144 weeks
Modification of the Estradiol (E2) levels
Time frame: 144 weeks
Percentage of participants experiencing miscarriage
Time frame: 144 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Individual participant dataSharing planned: No
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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.
ERICA VILLA, Prof. principal investigator
Gastroenterology Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ombitasvir-Paritaprevir-Ritonavir, Dasabuvir and Ribavirin in people with Chronic Hepatitis, C Virus, run by University of Modena and Reggio Emilia at 1 site in Italy.
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 7 inclusion and 10 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 1 Nov 2016. 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact ERICA VILLA, Prof. (+39 0594224359, erica.villa@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The modification of AMH levels (time frame: 48 weeks post treatment). 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 1 Nov 2016.