Chronic Hepatitis CPhase 4HEARTLANDNCT03710252
A Study to Investigate HCV Response Rates in Real World Patients: HEARTLAND Study
A Phase 4 study testing paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin in people with Chronic Hepatitis C, run by American Research Corporation.
Trial summary
This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Sep 2017
- 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
- Age ≥ 18 years
- Patients must have chronic GT 1 HCV infection (GT1a, GT1b or GT1a/1b)
- Patient and partner(s) must agree to use acceptable methods of contraception
- Patient must be able to read and understand English and/or Spanish
- Written informed consent
Who cannot join
- Currently taking or planning on taking any prohibited medications (see US PI)
- Evidence of decompensated liver disease (Child-Pugh B or C) including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy
- Abnormal lab values, including:
- Hemoglobin (Hgb) <8 g/dL
- Platelets <25,000 cells/mm3
- Absolute neutrophil count (ANC)<500 cells/mm3
Show all 12Show fewer
- Bilirubin >3
- INR>2.3 ALT/AST > 10 x ULN
- Serum albumin <2.8
- GFR <30 mL
- Alcohol use: >3 drinks per day consistently
- Uncontrolled HIV or HBV coinfection
About this study
Official title: A Study to Investigate HCV Response Rates in Real World Patients Traditionally Excluded From Clinical Trials: The HEARTLAND Study
This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting.
Read the detailed description
This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting.
The study will enroll chronically infected GT 1 patients who are treatment naïve or who have failed a regimen including pegIFN/RBV +/- telaprevir, boceprevir, or simeprevir.
In addition, up to 20 chronically infected GT1 patients who have traditionally been excluded from clinical trials due to mild to moderate renal insufficiency, irrespective of other co-morbid conditions including poorly controlled diabetes mellitus, high BMI, HIV infection will be enrolled.
- Conditions
- Chronic Hepatitis C
- Being tested
- paritaprevir/ritonavir/ombitasvir + 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.
paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirinDrug
OMB/PTV/r + DSV +/- RBV
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | Ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) + databuvir (DSV) +/- ribavirin (RBV) Receives: Drug: paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary analysis will be sustained virologic response 12 weeks after the last treatment dose (SVR12) for the all treated population.
Primary Analysis
Measured: 12 weeks after last treatment
Secondary outcomes (3)
Effect of baseline resistance variants on SVR12 (subgroups: all RAVs, different classes of RAVs)
Secondary Analysis
Measured: 12 weeks after last treatment
Evaluate patient reported outcomes via the SF36v2 survey (subgroups: those who achieve SVR12 and those who do not)
Secondary Analysis. Comparison between baseline and end of treatment
Measured: 12 weeks after last treatment
Evaluate patient adherence (subgroups: those who achieve SVR12 and those who do not)
Secondary Analysis
Measured: 12 weeks after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study startMar 2016
- Primary completionSep 2017
- Study completionSep 2017
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a Phase IV, open label, single arm study.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Research Corporation
- Sponsor type
- Research network
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Fred Poordad, MD, Principal investigator, American Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710252
- Sponsor's protocol ID
- TLI_IIS_01_2015
- Acronym
- HEARTLAND
- Status last verified
- Oct 2018
- First submitted
- 25 Sep 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate HCV Response Rates in Real World Patients Traditionally Excluded From Clinical Trials: The HEARTLAND Study
- ClinicalTrials.gov ID
- NCT03710252
- Acronym / sponsor ID
- HEARTLAND / TLI_IIS_01_2015
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- American Research CorporationResearch network
- Collaborators
- AbbVie
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 18 Oct 2018 (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 Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting.
Detailed description
This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting.
The study will enroll chronically infected GT 1 patients who are treatment naïve or who have failed a regimen including pegIFN/RBV +/- telaprevir, boceprevir, or simeprevir.
In addition, up to 20 chronically infected GT1 patients who have traditionally been excluded from clinical trials due to mild to moderate renal insufficiency, irrespective of other co-morbid conditions including poorly controlled diabetes mellitus, high BMI, HIV infection will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a Phase IV, open label, single arm study.
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Drug: paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirinOmbitasvir/paritaprevir/ritonavir (OBV/PTV/r) + databuvir (DSV) +/- ribavirin (RBV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
Key exclusion criteria (12 listed)
- Currently taking or planning on taking any prohibited medications (see US PI)
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 |
|---|---|---|
| paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirinOMB/PTV/r + DSV +/- RBV | Drug | Single |
Primary outcome
The primary analysis will be sustained virologic response 12 weeks after the last treatment dose (SVR12) for the all treated population.
Time frame: 12 weeks after last treatment
Primary Analysis
3 secondary outcomes
Effect of baseline resistance variants on SVR12 (subgroups: all RAVs, different classes of RAVs)
Time frame: 12 weeks after last treatment
Evaluate patient reported outcomes via the SF36v2 survey (subgroups: those who achieve SVR12 and those who do not)
Time frame: 12 weeks after last treatment
Evaluate patient adherence (subgroups: those who achieve SVR12 and those who do not)
Time frame: 12 weeks after last treatment
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 18 Oct 2018.
- 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.
Fred Poordad, MD principal investigator
American Research Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin in people with Chronic Hepatitis C, run by American Research Corporation.
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 5 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 18 Oct 2018. 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?
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?
The primary analysis will be sustained virologic response 12 weeks after the last treatment dose (SVR12) for the all treated population. (time frame: 12 weeks after last 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 18 Oct 2018.