AzTrials
AzTrials

Primary Biliary CholangitisPhase 3NCT03602560

ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

A Phase 3 study testing seladelpar 5-10 mg and seladelpar 10 mg in people with Primary Biliary Cholangitis, run by Gilead Sciences at 156 sites in 23 countries.

Completed

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

Official record
Search all trials

Trial summary

A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) The participants might enter the ongoing open-label safety study (NCT03301506)… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Biliary Cholangitis
What is being tested?
seladelpar 5-10 mg and seladelpar 10 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
265 participants
Where
156 sitesin 23 countries
Study dates
1 Oct 2018to 16 Feb 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have given written informed consent (signed and dated) and any authorizations required by local law
  • 18 to 75 years old (inclusive)
  • Male or female with a diagnosis of PBC, by at least two of the following criteria:
  • History of AP above ULN for at least six months
  • Positive anti-mitochondrial antibody (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay [ELISA]) or positive PBC-specific antinuclear antibodies
  • Documented liver biopsy result consistent with PBC
Show all 9Show fewer
  • On a stable and recommended dose of UDCA for the past twelve months OR intolerant to UDCA (last dose of UDCA > 3 months prior to Screening)
  • AP ≥ 1.67 × ULN
  • Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

Who cannot join

  • Previous exposure to seladelpar (MBX-8025)
  • A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
  • AST above 3 × ULN
  • ALT above 3 × ULN
  • Total bilirubin above 2.0 × ULN
  • Advanced PBC as defined by the Rotterdam criteria (albumin below LLN AND total bilirubin above 1 × ULN)
Show all 36Show fewer
  • Creatine kinase (CK) above 1.0 × ULN
  • eGFR below 60 mL/min/1.73 m2 (calculated by MDRD formula)
  • International normalized ratio (INR) above 1.0 × ULN
  • Platelet count below 100 × 103/µL
  • Presence of clinically significant hepatic decompensation, including:
  • History of liver transplantation, current placement on liver transplantation list, or current MELD score ≥ 15
  • Complications of portal hypertension, including known esophageal varices, history of variceal bleeds or related interventions (e.g., transjugular intrahepatic portosystemic shunt placement), relevant ascites, hepatic encephalopathy
  • Cirrhosis with complications, including history or presence of spontaneous bacterial peritonitis
  • Other chronic liver diseases:
  • Current features of auto-immune hepatitis as determined by the investigator based on immunoserology, liver biochemistry and histology
  • Primary sclerosing cholangitis determined by presence of diagnostic cholangiographic findings
  • History or clinical evidence of alcoholic liver disease
  • History or clinical evidence of alpha-1-antitrypsin deficiency
  • Biopsy confirmed nonalcoholic steatohepatitis
  • History or evidence of Gilbert' Syndrome with elevated total bilirubin
  • History or evidence of hemochromatosis
  • Hepatitis B defined as presence of hepatitis B surface antigen (HBsAg)
  • Hepatitis C defined as presence of HCV RNA
  • Known history of HIV
  • Evidence of significant alcohol consumption
  • Evidence of drug abuse
  • Subjects with inadequate response to obeticholic acid (OCA) or intolerance to OCA: OCA must be discontinued 30 days prior to Screening
  • Use of colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids (> 2 weeks) within two months prior to Screening
  • Use of fibrates within 30 days prior to Screening
  • Use of simvastatin within 7 days prior to Screening
  • Use of an experimental or unapproved treatment for PBC within 30 days prior to Screening
  • Use of experimental or unapproved immunosuppressant within 30 days prior to Screening
  • Treatment with any other investigational therapy or device within 30 days or within five half-lives, whatever is longer, prior to Screening
  • For females, pregnancy or breast-feeding
  • Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the investigator

Trial locations and contacts

156 sites in 23 countries.

156 sites in 23 countries

United States51 sites

  • Asheville Gastroenterology Associates, a Division of Digestive Health Partners, P.A.

    Asheville, North Carolina, 28801

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • Univeristy of Colorado Denver and Hospital

    Aurora, Colorado, 80045

  • Northeast Clinical Research Center, LLC

    Bethlehem, Pennsylvania, 18017

  • Excel Medical Clinical Trials, LLC

    Boca Raton, Florida, 33434

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02114

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Institute for Liver Health

    Chandler, Arizona, 85224

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • UH Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Liver Institute at Methodist Dallas

    Dallas, Texas, 75203

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Texas Digestive Disease Consultants

    Fort Worth, Texas, 76104

  • Gastro One

    Germantown, Tennessee, 38138

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • American Research Corporation

    Houston, Texas, 77030

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Indianapolis Gastroenterology Research Foundation

    Indianapolis, Indiana, 46237

  • Southern Therapy and Advance Research (STAR) LLC

    Jackson, Mississippi, 39216

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • GIA Clinical Trials, LLC

    Knoxville, Tennessee, 37909

  • Florida Reserach Institute

    Lakewood Rch, Florida, 34211

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Minnesota Gastroenterlogy, P.A.

    Maplewood, Minnesota, 55117

  • Schiff Center for Liver Diseases University of Miami

    Miami, Florida, 33136

  • University of Minnesota Medical Center, Fairview

    Minneapolis, Minnesota, 55455

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale School of Medicine Digestive Diseases, Internal Medicine

    New Haven, Connecticut, 06510

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Concorde Medical Group

    New York, New York, 10016

  • NYU Langone Health

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Center for Liver Disease and Transplantation

    New York, New York, 10032

  • Mary Immaculate Hospital

    Newport News, Virginia, 23602

  • Henry Ford Health System

    Novi, Michigan, 48377

  • Mayo Clinic Arizona - PPDS

    Phoenix, Arizona, 85054

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Stanford University School of Medicine

    Redwood City, California, 94063

  • Bon Secours Richmond Community Hospital

    Richmond, Virginia, 23226

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • American Research Corporation at Texas Liver Institute

    San Antonio, Texas, 78215

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Tampa General Medical Group

    Tampa, Florida, 33606

  • The Institute for Liver Health-Tucson

    Tucson, Arizona, 85711

  • Digestive Health Specialists PA

    Tupelo, Mississippi, 38801

Other trials in United States

Spain10 sites

  • Hospital Universitario Vall d'Hebrón - PPDS

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Germans Trias i Pujol

    Barcelona

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

United Kingdom10 sites

  • University Hospital Birmingham

    Birmingham, B15 2TT

  • Hull and East Yorkshire Hospitals NHS Trust

    Hull, HU3 2JZ

  • Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

    London, E1 1BB

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • Kings College Hospital

    London, SE5 9RS

  • The Newcastle Upon Tyne Hospital NHS Foundation Trust

    Newcastle, NE7 7DN

  • University of Nottingham

    Nottingham, NG7 2UH

  • Plymouth Hospitals NHS Trust

    Plymouth, PL6 8DH

  • Queen Alexandra Hospital

    Portsmouth, Hampshire, PO6 3LY

  • Singleton Hospital

    Swansea, SA2 8QA

Other trials in United Kingdom

Germany8 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Uniklinik Köln

    Cologne, North Rhine-Westphalia, 50937

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • ifi-Institute for Interdisciplinary Medicine

    Hamburg, 20246

  • Gastroenterologische Gemeinschaftspraxis Herne

    Herne, North Rhine-Westphalia, 44623

  • Gastroenterologisch Hepatologisches Zentrum Kiel

    Kiel, Schleswig-Holstein, 24146

  • Universitatsklinikum Leipzig

    Leipzig, 04103

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Israel8 sites

  • Hillel Yaffe Medical Center

    Hadera, 38100

  • Carmel Medical Center

    Haifa, 31048

  • Rambam Health Corporation

    Haifa, 31096

  • Hadassah Medical Center

    Jerusalem, 91120

  • The Galilli Medical Center

    Nahariya, 22100

  • Chaim Sheba Medical Center

    Ramat Gan, 52662

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

South Korea8 sites

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Hospital

    Daegu, 700-721

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Inje University Ilsan Paik Hospital

    Seoul, 03722

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 137 701

  • Severance Hospital Yonsei University Health System

    Seoul

Other trials in South Korea

Poland6 sites

  • Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-030

  • Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach

    Katowice, Silesian Voivodeship, 40-752

  • Wojewodzki Szpital Zespolony w Kielcach

    Kielce, 25-317

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 31-531

  • ID Clinic

    Mysłowice, 41-400

  • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Australia5 sites

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal Perth Hospital

    Perth, Western Australia, 6000

Other trials in Australia

Canada5 sites

  • University of Calgary Medicine

    Calgary, Alberta, T2N 4Z6

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • University Health Network

    Toronto, Ontario, M5G 2C4

  • Toronto Digestive Disease Associates Inc

    Vaughan, Ontario, M3N 2V7

  • University of Manitoba

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Italy5 sites

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo

    Milan, 20142

  • Ospedale Civile di Baggiovara

    Modena, 41126

  • Azienda Ospedaliera Di Padova

    Padova, 35128

  • ASST di Monza - Azienda Ospedaliera San Gerardo

    Rozzano, 20090

Other trials in Italy

Argentina4 sites

  • Fundación Sanatorio Güemes

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1180AAX

  • Hospital Universitario Austral

    Pilar, Buenos Aires, B1629AHJ

  • DIM Clínica Privada

    Ramos Mejía, B1704ETD

  • Hospital Provincial Del Centenario

    Rosario, Santa Fe Province, S2000KDS

Other trials in Argentina

Austria4 sites

  • LKH-Universitätsklinikum Klinikum Graz

    Graz, 8036

  • Salzburger Landeskliniken

    Salzburg, 5020

  • Medizinische Universitat Wien

    Vienna, State of Vienna, A-1090

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Hungary4 sites

  • Budai Hepatológiai Centrum

    Budapest, 1111

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, Csongrád megye, 6720

Other trials in Hungary

Romania4 sites

  • Colentina Clinical Hospital

    Bucharest, 020125

  • Fundeni Clinical Institute

    Bucharest, 022328

  • Sana Monitoring SRL

    Bucharest

  • Pius Brinzeu Emergency Clinical County Hospital

    Timișoara, Timiș County, 300723

Other trials in Romania

Belgium3 sites

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • UZ Leuven

    Leuven, Vlaams Brabant, 3000

Other trials in Belgium

Chile3 sites

  • Centro Clinico Mediterraneo

    La Serena, 1720506

  • Pontificia Universidad Catolica de Chile

    Santiago, Región-MetropolitanadeSantiago, 8330034

  • Centro de Investigaciones Clínicas Vina del Mar

    Viña del Mar, 2540364

Other trials in Chile

France3 sites

  • Hôpital Jean Verdier

    Bondy, 93140

  • CHU de GRENOBLE

    Grenoble, 38043

  • Hôpital Saint Antoine

    Paris, 75012

Other trials in France

Greece3 sites

  • University General Hospital of Heraklion

    Heraklion, 71110

  • University General Hospital of Larissa

    Larissa, 41110

  • University General Hospital of Patras

    Pátrai, 26504

Other trials in Greece

Mexico3 sites

  • Consultorio de la Doctora Maria Sarai Gonzalez Huezo

    Metepec, 52140

  • Consultorio Medico - Distrito Federal

    Mexico City, 06700

  • Centro de Diabetes y Obesidad Graber

    Pachuca, Hidalgo, 42086

Other trials in Mexico

New Zealand3 sites

  • Christchurch Hospital

    Christchurch, South Island, 8011

  • Dunedin Hospital

    Dunedin, South Island, 9001

  • Waikato Hospital

    Hamilton, 3240

Other trials in New Zealand

Russia3 sites

  • Peoples Friendship University of Russia

    Moscow, Moscow, 117198

  • City Hospital #31

    Saint Petersburg, 197110

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, 432063

Other trials in Russia

Serbia2 sites

  • Clinical Hospital Centar Zvezdara

    Belgrade, 11000

  • KBC Zemun

    Belgrade, 11080

Other trials in Serbia

Netherlands1 site

  • Radboud Universitair Medisch Centrum

    Nijmegen, Gelderland, 6525 GA

Other trials in Netherlands

About this study

Official title: A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.

Read the detailed description

Primary:

  • To evaluate the safety and effect on cholestasis of two seladelpar regimens (5 mg/day titrated to 10 mg/day and 10 mg/day) over 52 weeks of treatment compared to placebo

Key Secondary:

  • To evaluate the effect of seladelpar on normalization of alkaline phosphatase (AP) levels
  • To evaluate the effect of seladelpar on pruritus
Being tested
seladelpar 5-10 mg, seladelpar 10 mg, Placebo
Keywords
PBC, Primary Biliary Cholangitis (PBC)
Medical subject headings
Liver Cirrhosis, Biliary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • seladelpar 5-10 mgDrug

    Seladelpar 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects will continue the seladelpar dose (5 or 10 mg) received during the double-blinded study

  • seladelpar 10 mgDrug

    Seladelpar 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label safety study. Subjects will continue the seladelpar dose (10 mg) received during the double-blinded study

  • PlaceboDrug

    One capsule daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects on placebo will be re-randomized to initiate seladelpar at 5 or 10 mg once daily

Study groups in NCT03602560
Study groupRoleWhat they receive
Seladelpar 5-10 mgExperimentalNot described
Receives: Drug: seladelpar 5-10 mg
Seladelpar 10 mgExperimentalNot described
Receives: Drug: seladelpar 10 mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3

    Percentage of Participants with Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% reduction in ALP, and total bilirubin ≤ ULN) at Month 3. The mITT analysis set included all randomized subjects who received at least one study drug dose.

    The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: <350 U/L and 2:350 U/L; pruritus NRS: <4 and 2:4). The CMH tests were performed for the comparison of 10 mg versus placebo and 5 mg/10 mg versus placebo separately.

    Measured: Month 3

Secondary outcomes (2)

  1. Percentage of Participants With Response Defined by Normalized Alkaline Phosphatase Levels at Month 3

    The response was defined by normalized ALP levels (ALP ≤1.0 × ULN) at endpoint. The mITT analysis set included all randomized subjects who received at least one study drug dose.

    Measured: Month 3

  2. Change From Baseline in Pruritus NRS for Subjects With Baseline NRS ≥4 at Month 3

    Pruritus Numerical Rating Scale (NRS) used to rate the intensity of the worst itching you experienced in the past 24 hours from no itching to worst possible itching by selecting a number from 0 to 10 on Itch Scale. Zero means no itching and 10 means worst imaginable itching. The analysis will be limited to those subjects in the mITT analysis set with a baseline NRS ≥ 4.

    Measured: Month 3

Timeline

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

  1. First posted27 Jul 2018
  2. Study start1 Oct 2018
  3. Primary completion16 Feb 2020
  4. Study completion16 Feb 2020

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03602560
Sponsor's protocol ID
CB8025-31735
Status last verified
Jul 2022
First submitted
18 Jul 2018
Last updated
2 Aug 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Choi YJ, Schwab A, Lim J, Carlisle SM, McWherter CA, Johnson JD. Serum Metabolomic Profiling Reveals Potential Mechanisms and Biomarkers of Seladelpar Treatment in Patients With Primary Biliary Cholangitis. PPAR Res. 2026 Sep 25;2026:2362528. doi: 10.1155/ppar/2362528. eCollection 2026.

    PubMed 42798953

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing seladelpar 5-10 mg and seladelpar 10 mg in people with Primary Biliary Cholangitis, run by Gilead Sciences at 156 sites in 23 countries.

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 9 inclusion and 36 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 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, Spain, United Kingdom, Germany, Israel and 18 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Response to Composite Endpoint of ALP <1.67 × Upper Limit of Normal [ULN], ≥15% Reduction in ALP, and Total Bilirubin ≤ ULN) at Month 3 (time frame: Month 3). 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 NCT03602560, which also lists 1 linked publication.

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 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in