Hepatitis CPhase 4NCT03359746
Grazoprevir/Elbasvir for Treatment of Hepatitis C Virus Genotype 4 Post Kidney Transplant
A Phase 4 study testing Grazoprevir/Elbasvir in people with Hepatitis C, run by King Faisal Specialist Hospital & Research Center.
Trial summary
This is a prospective, interventional, case-control study at King Faisal Specialist Hospital \& Research Centre in post-renal transplant patients who are receiving Grazoprevir/Elbasvir combination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Grazoprevir/Elbasvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2017to 31 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible for participation in this trial, the subject must be:
- Male or female > 18 years on the day of consent signature.
- Post renal transplant with stable graft function divided into 2 groups according to Creatinine Clearance (CrCl <30 mL/min Or CrCl ≥30 mL/min).
- Positive HCV infection post renal transplant defined as: Positive HCV RNA with documented HCV Genotype 4 (including those with mixed infections with Genotype 4 \& Genotype 1 or Genotype 4 \& Genotype 6).
- Fibro scan (Liver Elastography) performed prior to the baseline with evidence of chronic HCV infection.
- Liver Cirrhosis subjects may be included but will be limited to those with compensated liver disease (Child Pugh-A)
- Patient understands the study procedures, alternative treatments available, risks involved with the study and voluntarily agree to participate by giving written informed consent.
- Reproductive potential patient agrees to avoid becoming pregnant or impregnating a partner until at least 6 months after the last dose of medication. Acceptable methods of contraception (IUD or contraceptive rod implanted into the skin may, or combination of two: diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide); cervical cap with spermicide (women only), male condom or female condom (cannot be used together), oral contraceptive pills: estrogen/progestine or progestin-only pill, contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection. Abstinence can be used as a sole method of contraception if it is consistently employed and considered acceptable by the patient and Institutional Review Board.
Who cannot join
- The subject must be excluded from participating in the trial if the subject:
- Is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
- Is infected with HCV Genotypes 1,2,3,5 or 6 except those with Genotype 1 or 6 with mixed infection with Genotype 4.
- Is co-infected with Hepatitis B Virus or HIV.
- Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease (Child Pugh-B or Child Pugh-C based on a platelet count below 75000 or an albumin below 3 g/dL)
- Pregnant or nursing female or male patient with pregnant female partner.
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- Contraindications for Grazoprevir/Elbasvir.
- Is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study.
- Has any condition or pre-study laboratory abnormality, ECG abnormality, or history of any illness, which, according to the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the subject.
- Patient has not signed informed consent form
Trial locations and contacts
No sites are listed yet.
About this study
This is a prospective, interventional, case-control study at King Faisal Specialist Hospital \& Research Centre in post-renal transplant patients who are receiving Grazoprevir/Elbasvir combination. Data will be compared with matched historical controls, which will be selected according to the following matching criteria: age, time from transplant to initiation of therapy. Only patients who completed at least 48 weeks of pegylated Interferon + Ribavirin therapy in the control group and 12 weeks of therapy on the case group will be enrolled. Any patient who received at least one dose of Grazoprevir/Elbasvir combination will be included in the safety analysis.
- Conditions
- Hepatitis C
- Being tested
- Grazoprevir/Elbasvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grazoprevir/ElbasvirDrug
Also called No other intervention
Medication for treatment of patient
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | This is a prospective, interventional, case-control study at King Faisal Specialist Hospital \& Research Centre in post-renal transplant patients who are receiving Grazoprevir/Elbasvir combination. Data will be compared with matched historical controls, which will be selected according to the following matching criteria: age, time from transplant to initiation of therapy. Only patients who completed at least 48 weeks of pegylated Interferon + Ribavirin therapy in the control group and 12 weeks of therapy on the case group will be enrolled. Any patient who received at least one dose of Grazoprevir/Elbasvir combination will be included in the safety analysis. Receives: Drug: Grazoprevir/Elbasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving sustained virologic response at 12 weeks after the end of all treatment (SVR12)
SVR12 was defined as HCV RNA below the lower limit of quantification (<LLOQ) at 12 weeks after the end of all study therapy. The primary efficacy hypothesis for this study is that the percentage of participants with Hepatitis C Virus (HCV) Genotype 4 post renal transplant achieving SVR12 with Grazoprevir/Elbasvir combination
Measured: 12 weeks after end of all therapy
Secondary outcomes (3)
Percentage of participants with change in circulating HCV RNA during treatment and after treatment discontinuation as compared to baseline.
Hepatitis C viral load refers to the amount of hepatitis C virus in a person's blood. The results of this test (known as a viral RNA test or HCV RNA test) are usually expressed as International Units/mL (IU/mL) or RNA copies/mL. The percentage of participants with change in circulating HCV RNA during treatment and after treatment discontinuation as compared to baseline will be reported.
Measured: 12 weeks during therapy
Percentage of participants with a decrease, no change, or increase between baseline and post treatment week 12 in kidney function as measured by Estimated Glomerular Filtration Rate and Albumin Creatinine Ratio (ACR)
Any worsening of a preexisting condition related to kidney function that was associated with the use of Elbasvir/Grazoprevir. The Percentage of participants with a decrease, no change, or increase between baseline and post treatment week 12 in kidney function as measured by Estimated Glomerular Filtration Rate and Albumin Creatinine Ratio (ACR) will be reported.
Measured: 12 weeks during therapy
Percentage of participants experiencing acute kidney transplant rejection compared to historical control.
Any worsening of a preexisting condition related to kidney transplant rejection that was associated with the use of Elbasvir/Grazoprevir. The percentage of participants experiencing acute kidney transplant rejection compared to historical control will be reported.
Measured: 12 weeks during therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start15 Dec 2017 (estimated)
- Primary completion31 Oct 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Faisal Abaalkhail, Md, Study chair, King Faisal Specialist Hospital & Research Centre, Riyadh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359746
- Sponsor's protocol ID
- RAC # 2171 009
- Status last verified
- Oct 2017
- First submitted
- 11 Oct 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grazoprevir/Elbasvir for Treatment of Hepatitis C Virus Genotype 4 Post Kidney Transplant
- ClinicalTrials.gov ID
- NCT03359746
- Acronym / sponsor ID
- RAC # 2171 009
- Conditions
- Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 15 Dec 2017 (estimated)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 2 Dec 2017 (actual)
- 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.
This is a prospective, interventional, case-control study at King Faisal Specialist Hospital \& Research Centre in post-renal transplant patients who are receiving Grazoprevir/Elbasvir combination. Data will be compared with matched historical controls, which will be selected according to the following matching criteria: age, time from transplant to initiation of therapy. Only patients who completed at least 48 weeks of pegylated Interferon + Ribavirin therapy in the control group and 12 weeks of therapy on the case group will be enrolled. Any patient who received at least one dose of Grazoprevir/Elbasvir combination will be included in the safety analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Grazoprevir/ElbasvirThis is a prospective, interventional, case-control study at King Faisal Specialist Hospital \& Research Centre in post-renal transplant patients who are receiving Grazoprevir/Elbasvir combination. Data will be compared with matched historical controls, which will be selected according to the following matching criteria: age, time from transplant to initiation of therapy. Only patients who completed at least 48 weeks of pegylated Interferon + Ribavirin therapy in the control group and 12 weeks of therapy on the case group will be enrolled. Any patient who received at least one dose of Grazoprevir/Elbasvir combination will be included in the safety analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female > 18 years on the day of consent signature.
- Post renal transplant with stable graft function divided into 2 groups according to Creatinine Clearance (CrCl <30 mL/min Or CrCl ≥30 mL/min).
- Positive HCV infection post renal transplant defined as: Positive HCV RNA with documented HCV Genotype 4 (including those with mixed infections with Genotype 4 \& Genotype 1 or Genotype 4 \& Genotype 6).
- Fibro scan (Liver Elastography) performed prior to the baseline with evidence of chronic HCV infection.
- Liver Cirrhosis subjects may be included but will be limited to those with compensated liver disease (Child Pugh-A)
Key exclusion criteria (10 listed)
- Is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
- Is infected with HCV Genotypes 1,2,3,5 or 6 except those with Genotype 1 or 6 with mixed infection with Genotype 4.
- Is co-infected with Hepatitis B Virus or HIV.
- Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease (Child Pugh-B or Child Pugh-C based on a platelet count below 75000 or an albumin below 3 g/dL)
- Pregnant or nursing female or male patient with pregnant female partner.
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 |
|---|---|---|
| Grazoprevir/ElbasvirAlso: No other interventionMedication for treatment of patient | Drug | Treatment Group |
Primary outcome
Percentage of participants achieving sustained virologic response at 12 weeks after the end of all treatment (SVR12)
Time frame: 12 weeks after end of all therapy
SVR12 was defined as HCV RNA below the lower limit of quantification (<LLOQ) at 12 weeks after the end of all study therapy. The primary efficacy hypothesis for this study is that the percentage of participants with Hepatitis C Virus (HCV) Genotype 4 post renal transplant achieving SVR12 with Grazoprevir/Elbasvir combination
3 secondary outcomes
Percentage of participants with change in circulating HCV RNA during treatment and after treatment discontinuation as compared to baseline.
Time frame: 12 weeks during therapy
Percentage of participants with a decrease, no change, or increase between baseline and post treatment week 12 in kidney function as measured by Estimated Glomerular Filtration Rate and Albumin Creatinine Ratio (ACR)
Time frame: 12 weeks during therapy
Percentage of participants experiencing acute kidney transplant rejection compared to historical control.
Time frame: 12 weeks during therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
Faisal Abaalkhail, Md study chair
King Faisal Specialist Hospital & Research Centre, Riyadh
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Grazoprevir/Elbasvir in people with Hepatitis C, run by King Faisal Specialist Hospital & Research Center.
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 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 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Faisal Abaalkhail, MD (966114424982 ext. 24982, abaalkhail@kfshrc.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants achieving sustained virologic response at 12 weeks after the end of all treatment (SVR12) (time frame: 12 weeks after end of all therapy). 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 2 Dec 2017.