NashPhase 4NCT01269320
Natural Soybean-derived Femarelle ®for Patients With Non Alcoholic Fatty Liver Disease
A Phase 4 study testing Femarelle in people with Nash, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This is a Single -arm, open-label, before-and after exploratory trial of 90 days of Femarelle ® to improve NAFLD and the metabolic syndrome. Ingestion of Femarelle will improve non alcoholic steatohepatitis and the metabolic syndrome in patients suffering from these conditions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nash
- What is being tested?
- Femarelle
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to not given
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven NASH
- If suffering from diabetes may be treated by up to 2 oral medications, with stable doses for 2 months.
- If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication.
- NOTE: Hormonal-based methods alone are not sufficient. At least two of the following methods MUST be used appropriately unless documentation of menopause, sterilization, or azoospermia is present:
- Condoms (male or female) with or without a spermicidal agent. - Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV transmission
- Diaphragm or cervical cap with spermicide
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- IUD
- Hormonal-based contraception
- Study subjects who are not of reproductive potential (girls who have not reached menarche or women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy and/or bilateral oophorectomy are eligible without requiring the use of contraceptives. Written or oral documentation communicated by clinician or clinician's staff is required by one of the following:
- Physician report/letter
- Operative report or other source documentation in the patient record (a laboratory report of azoospermia is required to document successful vasectomy)
- Discharge summary
- Laboratory report of azoospermia
- FSH measurement elevated into the menopausal range as established by the reporting laboratory.
- Ability and willingness of subject or legal guardian/representative to provide informed consent.
Who cannot join
- Pregnancy or Breast-Feeding
- Continuous use of the following medications for more than 3 days within 30 days of study entry:
- Immunosuppressives
- Immune modulators
- Systemic glucocorticoids
- Anti-neoplastic agents
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- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.
- Surgery within the previous 3 months.
- Any serious infectious, cardiac, pulmonary, or kidney disease
- Hypersensitivity to Femarelle ®
- Malignancy of the uterus or breast
- Past thromboembolic event
Trial locations and contacts
1 site in 1 country.
About this study
This is a Single -arm, open-label, before-and after exploratory trial of 90 days of Femarelle ® to improve NAFLD and the metabolic syndrome.
Ingestion of Femarelle will improve non alcoholic steatohepatitis and the metabolic syndrome in patients suffering from these conditions.
Subjects will receive treatment with Femarele 530 mg (1 capsule twice a day) for 90 days and will then be monitored off study treatment for an additional 4 weeks.
- Conditions
- Nash
- Being tested
- Femarelle
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemarelleDrug
Study treatment will consist of Femarelle, two 530mg oral tablets (equivalent to 322 mg of DT56a and 108 mg of Linum Usitatissimum extract each) twice a day for 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJan 2012
Why it stopped: Sponsors decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NashStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269320
- Sponsor's protocol ID
- 0172-10-HMO-CTIL
- Status last verified
- Aug 2011
- First submitted
- 3 Jan 2011
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Soybean-derived Femarelle ®for Patients With Non Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT01269320
- Acronym / sponsor ID
- 0172-10-HMO-CTIL
- Conditions
- Nash
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsors decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2012
- First posted
- 4 Jan 2011 (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.
This is a Single -arm, open-label, before-and after exploratory trial of 90 days of Femarelle ® to improve NAFLD and the metabolic syndrome.
Ingestion of Femarelle will improve non alcoholic steatohepatitis and the metabolic syndrome in patients suffering from these conditions.
Subjects will receive treatment with Femarele 530 mg (1 capsule twice a day) for 90 days and will then be monitored off study treatment for an additional 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Biopsy proven NASH
- If suffering from diabetes may be treated by up to 2 oral medications, with stable doses for 2 months.
- If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication.
- NOTE: Hormonal-based methods alone are not sufficient. At least two of the following methods MUST be used appropriately unless documentation of menopause, sterilization, or azoospermia is present:
- Study subjects who are not of reproductive potential (girls who have not reached menarche or women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy and/or bilateral oophorectomy are eligible without requiring the use of contraceptives. Written or oral documentation communicated by clinician or clinician's staff is required by one of the following:
Key exclusion criteria (13 listed)
- Pregnancy or Breast-Feeding
- Continuous use of the following medications for more than 3 days within 30 days of study entry:
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.
- Surgery within the previous 3 months.
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 |
|---|---|---|
| FemarelleStudy treatment will consist of Femarelle, two 530mg oral tablets (equivalent to 322 mg of DT56a and 108 mg of Linum Usitatissimum extract each) twice a day for 90 days | Drug | – |
Primary outcome
Not reported in the source record.
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 28 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Femarelle in people with Nash, run by Hadassah Medical Organization at 1 site in Israel.
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 15 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 28 Aug 2012. 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 Israel. 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?
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.
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 28 Aug 2012.