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Non Alcoholic Fatty Liver DiseasePhase 2NCT01999101

Safety Pilot Study of Farnesoid X Receptor (FXR) Agonist in Non-alcoholic Fatty Liver Disease (NAFLD) Patients

A Phase 2 study testing Px-104 in people with Non Alcoholic Fatty Liver Disease, run by Phenex Pharmaceuticals AG at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aim of the study is to evaluate the safety and tolerability of Px-104 in NAFLD patients and to assess the influence of Px-104 on hepatic fat. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non Alcoholic Fatty Liver Disease
What is being tested?
Px-104
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteAustria
Study dates
Oct 2013to Jun 2016
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • NAFLD patients
  • Weight > 65 kg
  • BMI > 25 and < 40
  • Negative blood or urine pregnancy test (for females of childbearing potential) collected at screening followed by another negative serum pregnancy test collected within 24 hours prior to the first dose of study drug.
  • Contraception: Female patients must be postmenopausal, surgically sterile, or if premenopausal, must be prepared to use at least two effective (≤1% failure rate) method of contraception during the course of the study and for 14 days after the end of dosing. Male patients with female partners of child bearing potential must be prepared to use at least two effective methods of contraception with all sexual partners unless they have had a prior vasectomy
  • Must be willing and able to give written informed consent and agree to comply with the study protocol.
  • Sinus rhythm in 12-lead ECG

Who cannot join

  • Evidence of excessive alcohol, drug or substance abuse (excluding marijuana use) within 1 year of first dose.
  • History or other evidence of a medical condition associated with chronic liver disease other than.
  • History or other evidence of decompensated liver disease (Child-Pugh Grade B or higher), coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, hepatic encephalopathy, and bleeding from esophageal varices are conditions consistent with decompensated liver disease.
  • Concomitant intake of fibrates or statins (at least 4-6 weeks before start; considering half life of medication).
  • Any clinically relevant findings in ECG (identified via 24h-Holter ECG or 12-Lead ECG) at screening
  • History of any structural cardiac disease.
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  • In addition, patients with documented or presumed unstable coronary artery disease, stable or unstable cardiovascular disease or cerebrovascular disease.
  • One or more of the following conditions: (1) poorly controlled hypertension, OR (2) screening or baseline blood pressure ≥ 160 mmHg for systolic OR (3) screening or baseline blood pressure ≥ 100 mmHg for diastolic blood pressure.
  • Type I or II diabetes with HbA1C > 6.5% at screening and/or fasting plasma glucose > 7mmol/L (> 126 mg/dl).
  • History or other evidence of a clinically relevant ophthalmologic disorder due to diabetes mellitus or hypertension or history or other evidence of severe retinopathy (e.g., cytomegalovirus, macular degeneration).
  • Known sensibility to any ingredients contained in the investigational medicinal product (IMP)
  • All conditions that do not allow magentic resonance (MR) assessments
  • History of having received any investigational drug ≤ 3 months and/or 6 x half-life prior to the first dose of study drug or the expectation that such drugs will be used during the study. Patients enrolled in this study cannot be enrolled in another study for either research, diagnostic or treatment purposes.
  • Woman with childbearing potential unless using adequate contraception (see inclusion criteria); females who are pregnant or breast feeding.
  • History of severe allergic
  • Evidence of an active or suspected cancer, or a history of malignancy within the last 2 years, with the exception of patients with basal cell carcinoma that has been excised and cured.
  • History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
  • History of bleeding disorders or anticoagulant use
  • History or other evidence of chronic pulmonary disease associated with functional limitation.
  • History of uncontrolled severe seizure disorder.
  • Poorly controlled thyroid dysfunction.
  • History of major organ transplantation with an existing functional graft.
  • Any signs of acute infection or inflammation
  • History or other evidence of severe illness, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
  • Any herbal supplements containing silymarin, tocopherol, vitamin C, riboflavins, proflavins, curcumin. (at least 4-6 months before the study)
  • Positive test at screening for anti-Hepatits A virus (HAV) Immunoglobulin M (IgM), Hebatitis B surface antigen (HBsAg), Anti-Hepatits B core Antigen Immunglobulin M antibody (anti-HBc IgM Ab), or anti-HIV Ab.
  • Subjects who have undergone surgery within the last 3 months.
  • Subjects who have had a prior gastrointestinal surgery.
  • Subjects who will be unavailable for the duration of the trial, who are unlikely to be compliant with the protocol, or who are felt to b unsuitable by the investigator for any other reason
  • Imprisonment

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Division of Gastroenterology and Hepatology, Department of Internal Medicine III

    Vienna, 1090

Other trials in Austria

About this study

Official title: A Safety Pilot Study of Px-104 in Non-alcoholic Fatty Liver Disease (NAFLD) Patients

The primary aim of the study is to evaluate the safety and tolerability of Px-104 in NAFLD patients and to assess the influence of Px-104 on hepatic fat.

Being tested
Px-104
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.

  • Px-104Drug

    28 days treatment

Study groups in NCT01999101
Study groupRoleWhat they receive
Px-104ExperimentalPx-104 capsules, 5 mg
Receives: Drug: Px-104

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

    Analysis of clinical chemistry, hematology, and assessment of clinical signs and adverse events over 28 days. Change day 28 vs. day 1

    Measured: 28 days

Secondary outcomes (5)

  1. Change of hepatocellular lipid content

    Measurement of hepatic fat (%) by Magnetic resonance spectroscopy (MRS), change day 28 vs. day 1

    Measured: day 1 and day 28

  2. Changes in oral glucose tolerance test (oGTT)

    Measurement of plasma glucose level (mg/dL)

    Measured: baseline and day 27

  3. Change from baseline in fibroblast growth factor 19 (FGF-19)

    Measurement by ELISA (pg/mL)

    Measured: days 1, 7, 14, 21 and 28

  4. Change from baseline in plasma bile acid concentration

    Assessment by LC-MS/MS (µmol/L)

    Measured: days 1, 7, 14, 21, and 28.

  5. Pharmacokinetics of Px-104 and conjugates

    Measurement by LC-MS/MS (ng/mL). AUC, Cmax and other pk parameters

    Measured: day 1 and day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJan 2015
  4. Study completionJun 2016

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01999101
Sponsor's protocol ID
PHS-Px-104-II-01
Status last verified
Nov 2014
First submitted
19 Nov 2013
Last updated
29 Sep 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Px-104 in people with Non Alcoholic Fatty Liver Disease, run by Phenex Pharmaceuticals AG at 1 site in Austria.

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 30 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 29 Sep 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 Austria. 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 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 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?

Safety (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01999101.

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 29 Sep 2016.

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