Treatment of liver fibrosis: Past, current, and future

Table 1 Completed clinical trials (Clinicaltrials.gov, accession date: March 1, 2023)

Method	Intervention	Trial number	Phase	Title	Condition
Biological	Peginterferon alfa-2b (SCH 54031)	NCT00049842	3	Prevention of Disease Progress in Chronic Hepatitis C Patients with Liver Fibrosis (Study P02570AM2)	Chronic HCV; Liver fibrosis
	PegIntron (peginterferon alfa-2b; SCH 54031) REBETOL (ribavirin; SCH 18908)	NCT00039871	3	PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)	Hepatitis; HCV; Fibrosis; Liver cirrhosis
	Simtuzumab	NCT01707472	2	Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults with Liver Fibrosis	Liver fibrosis; HCV infection; HIV
	Simtuzumab	NCT01672853	2	Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults with PSC	PSC
Dietary regulation	GK#10; Placebo	NCT01598064	N/A	Probiotics for Liver Cirrhosis with Portal Hypertension	Liver cirrhosis; Portal hypertension
Drug	Aramchol	NCT02279524	2	A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH	Fatty liver; NASH; Liver fibrosis
	BI 201335	NCT01909778	1	Open Label Single Dose Phase I Trial of BI 201335 to Study Pharmacokinetics and Safety in Patients with Compensated Liver Cirrhosis	HCV; Liver cirrhosis
	BMS-986036; Placebo	NCT03486912	2	A Study of Experimental Medication BMS-986036 in Adults with NASH and Liver Cirrhosis	Hepatic cirrhosis; Liver fibrosis; NAFLD; NASH
	BMS-98603; Other: Placebo	NCT03486899	2	A Study of Experimental Medication BMS-986036 in Adults with NASH and Stage 3 Liver Fibrosis	Liver fibrosis; NAFLD; NASH
	BMS-986263 placebo	NCT03420768	2	A Study of Experimental Medication BMS-986263 in Adults with Advanced Hepatic Fibrosis After Cure of Hepatitis C	Hepatic cirrhosis; Liver fibrosis
	Cenicriviroc placebo	NCT02217475	2	Efficacy and Safety Study of Cenicriviroc for the Treatment of NASH in Adult Participants with Liver Fibrosis	NASH
	CRV431 placebo	NCT04480710	2	A Study of CRV431 Dosed Once Daily in NASH-induced F2 and F3 Subjects	NASH; Fibrosis; NAFLD
	Fuzheng Huayu placebo	NCT00854087	2	Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients with Hepatic Fibrosis	Chronic HCV
	GI262570 placebo	NCT00244751	2	Antifibrotic Activity of GI262570 In Chronic Hepatitis C Subjects	Cirrhosis, liver
	GR-MD-02 placebo	NCT02462967	2	Clinical Trial to Evaluation the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients with Nash Cirrhosis	Hypertension, portal
	GR-MD-02; Placebo	NCT02421094	2	Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients with NASH With Advanced Fibrosis	NASH
	IDN-6556; Placebo	NCT02230670	2	A Study of IDN-6556 in Subjects with Liver Cirrhosis	Liver cirrhosis; Hepatic cirrhosis
	IDN-6556; Placebo	NCT02138253	2	A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV	Liver fibrosis; Liver cirrhosis
	INT-747; Ursodeoxycholic acid; Placebo	NCT00550862	2	Study of INT 747 in Combination with URSO in Patients with PBC	Liver cirrhosis; Biliary injury
	Nitazoxanide; BID	NCT03656068	2	An Evaluation of the Safety and Efficacy of Nitazoxanide on Collagen Turnover in NASH Patients with Fibrosis	NASH; Fatty liver; Fibrosis; Compensated cirrhosis
	Placebo obeticholic acid	NCT00570765	2	Study of INT-747 as Monotherapy in Participants with PBC	Liver cirrhosis, biliary injury
	SEL; Simtuzumab	NCT02466516	2	Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination with Simtuzumab in Adults with NASH and Fibrosis Stages F2-F3	NASH
	Simeprevir; Daclatasvir; Sofosbuvir	NCT02349048	2	Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants with Chronic HCV Genotype 1 Infection	HCV
	Tropifexor (LJN452) CVC	NCT03517540	2	Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients with NASH and Liver Fibrosis	NASH
	Peginterferon alfa-2a + Ribavirin; Peginterferon alfa-2a	NCT00006164	3	Long Term Interferon for Patients Who Did Not Clear HCV with Standard Treatment	Chronic HCV; Cirrhosis; Fibrosis; Hepatic cirrhosis
	OMACOR placebo oral capsule	NCT00760513	4	Treatment of non-Alcoholic Fatty Liver Disease With n-3 Fatty Acids	NAFLD
	Ceftriaxone normal saline	NCT04218695	4	Prophylactic Antibiotics in Admitted Cirrhotics	Cirrhosis, LIVER
	Proton pump inhibitors placebo	NCT03175731	4	PPIs and Gastroesophageal Varices in Liver Cirrhosis (PPIs: Proton pump inhibitors)	Liver cirrhosis; Hypertension, portal
Other	Human fetal liver cell transplantation	NCT01013194	1 or 2	Human Fetal Liver Cell Transplantation in Chronic Liver Failure	Liver cirrhosis
	G-colony stimulating factor and infusion of the mobilized monocyte cells	NCT01503749	1	Safety and Efficacy Study of Peripheral Blood Mononucleated Cells for Treatment of Liver Cirrhosis	Liver cirrhosis
	Leukapheresis; Infusion of stem cells via image-guided scan	NCT00147043	N/A	Adult Stem Cell Therapy in Liver Insufficiency	Liver cirrhosis

N/A: Not applicable; CVC: Cenicriviroc; HCV: Hepatitis C virus; HIV: Human immunodeficiency virus; NAFLD: non-alcoholic fatty liver disease; NASH: Nonalcoholic steatohepatitis; PBC: Primary biliary cirrhosis; PSC: Primary sclerosing cholangitis.