Clinical trials: Digestive Disease
Pancreatic Disease
A Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers
The following are the study hypothesis: Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples being predominantly of exocrine pancreas origin when…
- Trial name
- CRC2006-05 (NCT01087801)
- Testing
- ChiRhoStim
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- ChiRhoClin, Inc.
Hepatitis C, Chronic
A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin).
- Trial name
- NCT01429792
- Testing
- peginterferon alfa-2a [Pegasys], ribavirin [Copegus]
- Where
- 26 sites in Israel
- Volunteers
- 1,013 people
- Sponsor
- Hoffmann-La Roche
Inflammatory Bowel Disease
Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
The primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease (IBD).
- Trial name
- MANTA (NCT03201445)
- Testing
- Filgotinib, Standard of Care
- Where
- 56 sites in United States, Australia and 9 more
- Volunteers
- 139 people
- Sponsor
- Lakefront Biotherapeutics NV
GIST
A Phase 2 Trial of Ponatinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor
The purpose of this study is to evaluate the efficacy and safety of ponatinib in participants with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) following failure of prior tyrosine kinase inhibitor (TKI)…
- Trial name
- GIST (NCT01874665)
- Testing
- Ponatinib
- Where
- 4 sites in United States
- Volunteers
- 45 people
- Sponsor
- Ariad Pharmaceuticals
Non-Alcoholic Steatohepatitis (NASH), Type2 Diabetes Mellitus
A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)
This is an open, pilot study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM or pre-diabetes.
- Trial name
- NCT02653300
- Testing
- Oral Insulin
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Oramed, Ltd.
Opioid-induced Constipation
A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
- Trial name
- NCT01443403
- Testing
- Naldemedine
- Where
- 49 sites in United States
- Volunteers
- 244 people
- Sponsor
- Shionogi
Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma
Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma
The primary objective of this study was to assess the preliminary antitumor activity as indicated by overall response rate (ORR) of tislelizumab in combination with lenvatinib in participants with unresectable locally advanced or…
- Conditions
- Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
- Trial name
- NCT04401800
- Testing
- Lenvatinib, Tislelizumab
- Where
- 9 sites in China
- Volunteers
- 64 people
- Sponsor
- BeiGene
Alpha1-antitrypsin Deficiency
Aralast alpha1-proteinase Inhibitor Surveillance Study
The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are initiating treatment with ARALAST on…
- Trial name
- NCT00313144
- Testing
- ARALAST Alpha1-Proteinase Inhibitor
- Where
- United States
- Volunteers
- 127 people
- Sponsor
- Baxalta now part of Shire
Primary Biliary Cholangitis
Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
This is an observational, retrospective cohort study of patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment, using a real-world data source, the Komodo Health United States (US) claims…
- Trial name
- HEROES PBC (NCT05292872)
- Where
- United States
- Volunteers
- 4,577 people
- Sponsor
- Intercept Pharmaceuticals
Crohn's Disease
Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.
- Trial name
- NCT03870334
- Testing
- BT-11 880 mg
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- NImmune Biopharma
Chronic Hepatitis C (CHC)
Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C
This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.
- Trial name
- NCT01753557
- Testing
- MP-424, RBV, PEG-IFN alfa-2a
- Where
- Japan
- Volunteers
- 54 people
- Sponsor
- Tanabe Pharma Corporation
Short Bowel Syndrome
Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome
A new Enteric-Coated Cholestyramine (ECC) capsule has been developed to manage diarrhea associated with Short Bowel Syndrome (SBS) in adults.
- Trial name
- NCT04046328
- Testing
- Enteric-Coated Cholestyramine (ECC) Capsule
- Where
- 3 sites in Poland
- Volunteers
- 13 people
- Sponsor
- Pharmascience Inc.
Hepatic Insufficiency
The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009)
The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic insufficiency compared with healthy controls.
- Trial name
- NCT01797536
- Testing
- Elbasvir
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF3 (NCT00128492)
- Testing
- AZLI 75 mg two times a day (BID)/ three times a day (TID)
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 274 people
- Sponsor
- Gilead Sciences
Pseudomonas Aeruginosa Respiratory Tract Infection/Colonization, Cystic Fibrosis
Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa…
- Trial name
- ALPINE 2 (NCT03219164)
- Testing
- AZLI
- Where
- 53 sites in United States, Austria and 10 more
- Volunteers
- 149 people
- Sponsor
- Gilead Sciences
Non-Alcoholic Steatohepatitis
Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in overweight and obese adults.
- Trial name
- NCT02287779
- Testing
- SHP626
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Mirum Pharmaceuticals, Inc.
Fecal Incontinence
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
- Trial name
- TRANSFORM (NCT01090739)
- Testing
- TOPAS Treatment for Fecal Incontinence
- Where
- 14 sites in United States
- Volunteers
- 207 people
- Sponsor
- ASTORA Women's Health
Bardet-Biedl Syndrome, POMC Deficiency
Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway
A trial to compare the weekly and daily formulations of setmelanotide in participants with genetic defects in the melanocortin-4 receptor pathway.
- Trial name
- NCT05194124
- Testing
- Setmelanotide 2 mg, Setmelanotide 2.5 mg, Setmelanotide 3 mg
- Where
- 7 sites in United States, Canada and 4 more
- Volunteers
- 19 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Chronic Hepatitis B
Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Selgantolimod (Formerly GS-9688) in Viremic Adult Participants With Chronic Hepatitis B (CHB) Who Are Not Currently on Treatment
The primary objectives of this study are to evaluate the safety and tolerability of multiple oral doses of selgantolimod and to evaluate the antiviral activity of selgantolimod in adult participants with chronic hepatitis B (CHB)…
- Trial name
- NCT03615066
- Testing
- Selgantolimod, TAF
- Where
- 10 sites in Canada, South Korea and 1 more
- Volunteers
- 67 people
- Sponsor
- Gilead Sciences
Wilson Disease
Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease
This study is being conducted to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of ALXN1840 versus standard of care in pediatric participants with Wilson disease (WD).
- Trial name
- NCT05047523
- Testing
- ALXN1840, Standard of Care
- Where
- 20 sites in Australia, France and 5 more
- Volunteers
- 40 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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