Clinical trials: NAS
Non-Alcoholic Steatohepatitis
Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to determine if the investigational treatment volixibat (SHP626) is safe, tolerable and effective in adults with nonalcoholic steatohepatitis (NASH).
- Trial name
- NCT02787304
- Testing
- SHP626
- Where
- 65 sites in United States, Canada and 2 more
- Volunteers
- 197 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Hepatitis B, Chronic
Tenofovir Disoproxil Fumarate (TDF) 300mg 3 Years RD Therapy Chinese Chronic Hepatitis B (CHN) CHB Multiple Nucleos(t)Ide Analogues (NAs) Failure Points Pts PH4 PMS Study
This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues (NAs).
- Trial name
- NCT02195518
- Testing
- Tenofovir disoproxil fumarate
- Where
- 12 sites in China
- Volunteers
- 213 people
- Sponsor
- GlaxoSmithKline
Neonatal Abstinence Syndrome
Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process
Substance abuse during pregnancy is on the rise through both prescribed and illicit use of controlled substances, which has increased neonatal abstinence syndrome (NAS).
- Trial name
- NCT06303986
- Testing
- NeoMonki
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Rekovar Inc.
Steatohepatitis, Nonalcoholic
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224
The purpose of this study is to assess the effect of multiple ION224 doses when administered by subcutaneous (SC) injection for 49 weeks (end of the treatment [EOT]) on non-alcoholic steatohepatitis (NASH) histologic improvement…
- Trial name
- NCT04932512
- Testing
- ION224
- Where
- 51 sites in United States, Puerto Rico
- Volunteers
- 160 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Neonatal Abstinence Syndrome
tAN to Mitigate Withdrawal Behaviors in Neonates
This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether.
- Trial name
- NCT04588519
- Testing
- Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Spark Biomedical, Inc.
Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.
- Trial name
- PROXYMO-ADV (NCT05364931)
- Testing
- Cotadutide
- Where
- 115 sites in United States, Argentina and 18 more
- Volunteers
- 54 people
- Sponsor
- AstraZeneca
Chronic Hepatitis b
Phase IIIB Extension Clinical Trial of Efficacy and Safety of GST-HG141 (Nairevir) Combined With NAs in Chronic Hepatitis B
This is a multicenter, single-arm, open-label, phase IIIb extension clinical trial designed to evaluate the long-term safety and tolerability of GST-HG141 (nerlecovir, 50 mg BID) in combination with nucleos(t)ide analogues (NAs)…
- Trial name
- NCT07588009
- Testing
- GST-HG141
- Volunteers
- 576 people
- Sponsor
- Fujian Akeylink Biotechnology Co., Ltd.
Hepatitis B
A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients
The purpose of this study is to evaluate the efficacy and safety of GC1102 in combination of Nucleo(t)ide analogues (NAs) in patients with chronic hepatitis B
- Trial name
- NCT03801798
- Testing
- GC1102
- Where
- South Korea
- Volunteers
- 42 people
- Sponsor
- Green Cross Corporation
Chronic Hepatitis B
A Phase II Clinical Study of the Efficacy and Safety of HRS9950 Tablets in Chronic Hepatitis B Patients Who Are Virologically Suppressed on Nucleoside or Nucleotide Analogues (NAs)
To evaluate the efficacy and safety of HRS9950 tablets in chronic hepatitis B patients who are virologically suppressed on nucleoside or nucleotide analogues (NAs).
- Trial name
- NCT05905458
- Testing
- HRS9950 tablets
- Where
- China
- Volunteers
- 54 people
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Chronic Hepatitis B
A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs
This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of AHB-137 injection in combination with other hepatitis B drugs in participants with HBeAg-negative CHB treated with NAs.
- Trial name
- NCT07069569
- Testing
- AHB-137, Peg-IFN, Hepatitis B Vaccine
- Where
- 14 sites in China
- Volunteers
- 200 people
- Sponsor
- Ausper Biopharma Co., Ltd.
Nonalcoholic Fatty Liver Disease
The Study of Multiple Doses of CM-101 in Male and Female NAFLD (Nonalcoholic Fatty Liver Disease) and NAFLD/NASH (Nonalcoholic Steatohepatitis) Subjects
A two-part study for NAFLD subjects with normal liver functions and in general good health to be treated with CM-101 or matching placebo and NAFLD/NASH Activity Score (NAS) < 3 that are in general good health and have normal…
- Trial name
- NCT06044467
- Testing
- Anti-human CCL24 monoclonal antibody (CM-101) - Part One, Anti-human CCL24 monoclonal antibody (CM-101) - Part Two
- Where
- Israel
- Volunteers
- 16 people
- Sponsor
- ChemomAb Ltd.
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Neurostimulation to Improve NOWS Outcomes
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
- Trial name
- SPROUT (NCT05129020)
- Testing
- Sparrow Fledging Therapy System
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- Spark Biomedical, Inc.
Chronic Hepatitis B
Clinical Trial of TQA3605 Tablet in Combination With Nucleos(t)Ide Analogues(NAs) Versus NAs Alone for the Treatment of Patients With Chronic Hepatitis B Virus Infection Who Have Undergone Treatment and Exhibit Low Viral Load or Poor Response
This is a multicenter, randomized, double-blind, placebo-controlled Phase III study with an open-label extension. The purpose is to evaluate efficacy and safety in adult patients with chronic hepatitis B virus infection who have…
- Trial name
- NCT07797231
- Testing
- TQA3605 tablets, Entecavir dispersible tablets, Tenofovir Disoproxil Fumarate Tablets
- Where
- 77 sites in China
- Volunteers
- 930 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Neonatal Abstinence Syndrome
Donor Human Milk in Neonatal Abstinence Syndrome
This study is designed to develop pilot data on the acceptability and benefit of donor human milk for infants undergoing pharmacologic treatment for NAS.
- Trial name
- DHM&NAS (NCT02182973)
- Testing
- donor human milk
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neolac Inc dba Medolac Laboratories
Hepatitis B, Chronic
A Study to Evaluate the Safety and Efficacy of AHB-137 in Healthy Participants and HBeAg-negative Chronic Hepatitis B (CHB) Patients
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy participants after single and multiple doses, and evaluate the preliminary efficacy of AHB-137…
- Trial name
- NCT06115993
- Testing
- AHB-137 injection
- Where
- 3 sites in China
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Ausper Biopharma Co., Ltd.
Chronic Hepatitis B
Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)
This study is a randomized, double-blind, multicenter phase 3 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.
- Trial name
- NCT07246889
- Testing
- AHB-137, NA therapy
- Where
- 28 sites in China
- Volunteers
- 577 people
- Sponsor
- Ausper Biopharma Co., Ltd.
Chronic Hepatitis B
A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied.
- Trial name
- NCT04846491
- Testing
- Peginterferon alfa-2b injection, TDF
- Where
- 33 sites in China
- Volunteers
- 475 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Hepatitis B, Chronic
A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression
This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in participants with HBeAg-negative chronic hepatitis B…
- Trial name
- NCT01706575
- Testing
- Pegylated Interferon (Peginterferon) Alfa-2a, Nucleos(t)ide Analogues (NA)
- Where
- 27 sites in Italy
- Volunteers
- 76 people
- Sponsor
- Hoffmann-La Roche
HBV Infection With LLV
Clinical Study of TQA3605 Tablets Combined With Nucleoside (Acid) Analogs (NAs) Drugs Compared With NAs Drugs in the Treatment of Chronic Hepatitis B Virus (HBV) Infection
This study is a phase II multicenter, randomized, double-blind, placebo controlled study designed to evaluate the efficacy and safety in LLV subjects and demonstrate that TQA3605 tablets combined with oral NAs drugs can improve…
- Trial name
- NCT06644417
- Testing
- TQA3605 tablets plus NAs
- Where
- 19 sites in China
- Volunteers
- 122 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Chronic Hepatitis B
A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHB
This study is divided into two parts. Part A is a multicenter, randomized, double-blind, placebo controlled phase Ill clinical trial, designed to evaluate the efficacy and safety of ZM-H1505R in combination with NAs versus NAs…
- Trial name
- NCT07095855
- Testing
- ZM-H1505R 100mg, NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatments
- Where
- China
- Volunteers
- 1,300 people
- Sponsor
- Shanghai Zhimeng Biopharma, Inc.