Hepatitis CPhase 2NCT00930995
Angiotensin Receptor Blockade as an Anti-Fibrotic Intervention in Patients With Chronic Hepatitis C
A Phase 2 study testing Candesartan in people with Hepatitis C, run by Kaiser Permanente at 2 sites in United States.
Trial summary
Hepatitis C is the most common reason for liver transplantation in the United States and affects nearly 4 million Americans. Treatments for hepatitis C are available but are poorly tolerated and are not always effective. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Candesartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, age 21 and older
- Patients with viral hepatitis C that are not on interferon based therapy.
- Detectable viral load
- Baseline biopsy within six months or willing to undergo biopsy prior to drug initiation
- At least grade 2 inflammation on biopsy, fibrosis of stage 1 or higher
- Willing to undergo biopsy at the end of treatment
- No interferon for at least 6 months prior to or after initial biopsy for study
Who cannot join
- Renal impairment defined by a serum creatinine of >1.8
- Congestive heart failure
- Hepatocellular cancer
- Concurrent treatment with pentoxyfylline, steroids, interferon alpha or interferon gamma.
- Active psychosis (affective disorders without loss of reality testing acceptable)
- Active IV drug use
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- Prior liver transplant
- Pregnancy
- Decompensated cirrhosis as defined by the presence of ascites, hepatic encephalopathy or coagulopathy with an INR>1.4
- HIV seropositivity
- Hypotension defined by a baseline systolic blood pressure of less than 90mm of mercury
- Contraindication to ARB use or allergy to medication
- Treatment with potassium sparing diuretics
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente
Roseville, California, 95661
Kaiser Permanente
Sacramento, California, 95825
About this study
Official title: Angiotensin Receptor Blockade an Anti-Fibrotic Intervention in Patients With Chronic Hepatitis C
Hepatitis C is the most common reason for liver transplantation in the United States and affects nearly 4 million Americans. Treatments for hepatitis C are available but are poorly tolerated and are not always effective. Morbidity and mortality from hepatitis C are related to the development and progression of hepatic fibrosis to cirrhosis and end stage liver disease. Efforts to block progression of liver disease would thus result in prevention of morbidity and mortality as well as costs incurred by the health system in the care of these conditions.
Scar tissue in the liver is secreted by a type of cell, called the stellate cell, in an activated state. This cell carries a receptor for angiotensin, a hormone, when activated. If this receptor is blocked, the cell becomes inactive and does not participate in scar tissue formation. Thus, we hypothesize that using a drug such as candesartan, which blocks angiotensin receptors, should result in less scar tissue formation in the livers of patients with hepatitis C.
- Conditions
- Hepatitis C
- Being tested
- Candesartan, Placebo
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandesartanDrug
Also called Atacand
16mg po daily
PlaceboDrug
once daily
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Candesartan |
| B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: • Stellate cell activity by alpha SMA stain quantitated by morphometry
Measured: 48 weeks
• Hepatic fibrosis by morphometry
Measured: 48 weeks
Secondary outcomes (2)
Surrogate markers for fibrosis (liver TGF-beta levels, serum procollagen-III peptide levels)
Measured: 48 weeks
Functional status- Albumin, INR, T. Bilirubin, MELD score
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
Why it stopped: Not Awarded
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.
- More trials run by Kaiser PermanenteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Investigators
- Sripriya Subramanian, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930995
- Sponsor's protocol ID
- CN-05SBala-01-B
- Status last verified
- Apr 2012
- First submitted
- 1 Jul 2009
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiotensin Receptor Blockade an Anti-Fibrotic Intervention in Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00930995
- Acronym / sponsor ID
- CN-05SBala-01-B
- Conditions
- Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not Awarded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- University of California, Davis
- First posted
- 2 Jul 2009 (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 is the most common reason for liver transplantation in the United States and affects nearly 4 million Americans. Treatments for hepatitis C are available but are poorly tolerated and are not always effective. Morbidity and mortality from hepatitis C are related to the development and progression of hepatic fibrosis to cirrhosis and end stage liver disease. Efforts to block progression of liver disease would thus result in prevention of morbidity and mortality as well as costs incurred by the health system in the care of these conditions.
Scar tissue in the liver is secreted by a type of cell, called the stellate cell, in an activated state. This cell carries a receptor for angiotensin, a hormone, when activated. If this receptor is blocked, the cell becomes inactive and does not participate in scar tissue formation. Thus, we hypothesize that using a drug such as candesartan, which blocks angiotensin receptors, should result in less scar tissue formation in the livers of patients with hepatitis C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Candesartan |
| B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults, age 21 and older
- Patients with viral hepatitis C that are not on interferon based therapy.
- Detectable viral load
- Baseline biopsy within six months or willing to undergo biopsy prior to drug initiation
- At least grade 2 inflammation on biopsy, fibrosis of stage 1 or higher
Key exclusion criteria (13 listed)
- Renal impairment defined by a serum creatinine of >1.8
- Congestive heart failure
- Hepatocellular cancer
- Concurrent treatment with pentoxyfylline, steroids, interferon alpha or interferon gamma.
- Active psychosis (affective disorders without loss of reality testing acceptable)
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 |
|---|---|---|
| CandesartanAlso: Atacand16mg po daily | Drug | A |
| Placeboonce daily | Drug | B |
Primary outcome
Primary: • Stellate cell activity by alpha SMA stain quantitated by morphometry
Time frame: 48 weeks
• Hepatic fibrosis by morphometry
Time frame: 48 weeks
2 secondary outcomes
Surrogate markers for fibrosis (liver TGF-beta levels, serum procollagen-III peptide levels)
Time frame: 48 weeks
Functional status- Albumin, INR, T. Bilirubin, MELD score
Time frame: 48 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
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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.
Sripriya Subramanian, MD, MPH principal investigator
Kaiser Permanente
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Candesartan in people with Hepatitis C, run by Kaiser Permanente at 2 sites in United States.
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 13 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: withdrawn, as of the sponsor's last update on 25 Apr 2012. 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Primary: • Stellate cell activity by alpha SMA stain quantitated by morphometry (time frame: 48 weeks). The study lists 2 primary outcomes in all. 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 25 Apr 2012.