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Digestive System

Recruiting

Microbiota restoration therapy for recurrent C-difficile infections

The purpose of this study is to evaluate safety via assessment of treatment-emergent adverse events and efficacy of RBX2660 preventing recurrent episodes of CDI measured at eight weeks after treatment. 

Status
Recruiting
Principal Investigator
Theodore Steiner
Body Locations and Systems
Digestive System
Age
18 and above

Tapering dose of vancomycin to prevent recurrent C. difficile infection

Clostridium difficile infection (CDI) affects 37,000 patients in Canada annually. Even with successful treatment, approximately 25 per cent of patients develop recurrent CDI within eight weeks. The purpose of this study is to investigate whether the extension of initial treatment from 14 to 28 days with a tapering dose of vancomycin will help prevent recurrent CDI in the future.

Status
Recruiting
Principal Investigator
Theodore Steiner
Body Locations and Systems
Digestive System
Age
18 and above

Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection

The purpose of this study is to compare the effectiveness of freeze dried fecal filtrate (no live bacteria) to freeze dried fecal transplant (live bacteria present) in treating recurrent C. difficile infection.

Status
Recruiting
Principal Investigator
Theodore Steiner
Body Locations and Systems
Clostridium Difficile Infections
Area
Vancouver
Age
18 and above

Safety, Tolerability, and Efficacy of GS-9674 in Adults With Primary Sclerosing Cholangitis Without Cirrhosis (PSC-Phase 2)

The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in adults with primary sclerosing cholangitis (PSC).

Status
Recruiting
Principal Investigator
Eric Yoshida
Body Locations and Systems
Liver Diseases
Area
Vancouver
Age
18-70 years

Safety, Tolerability, and Efficacy of GS 9674 in Adults With Primary Biliary Cholangitis Without Cirrhosis (PBC-Phase 2

The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in adults with primary biliary cholangitis (PBC).

Status
Recruiting
Principal Investigator
Eric Yoshida
Body Locations and Systems
Liver Diseases
Area
Vancouver
Age
18-70 years

Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease (SOF/VEL ESRD)

The primary objectives of this study are to evaluate safety, efficacy and tolerability of treatment with sofosbuvir (Sovaldi®)/velpatasvir (Epclusa®; SOF/VEL) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection who are on dialysis for End Stage Renal Disease (ESRD).

Status
Recruiting
Principal Investigator
Eric Yoshida
Body Locations and Systems
Hepatitis C
Area
Vancouver
Age
18 years and above

A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

The study is to evaluate the long-term safety of oral GED-0301 (mongersen) in subjects with Crohn's Disease.

 

 

Status
Recruiting
Principal Investigator
Baljinder Salh
Body Locations and Systems
Crohn's Disease
Area
Vancouver
Age
18 and above

Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients diagnosed with moderate to severe ulcerative colitis.

Status
Recruiting
Principal Investigator
Baljinder Salh
Body Locations and Systems
Ulcerative Colitis
Area
Vancouver
Age
18-75

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)

The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Status
Recruiting
Principal Investigator
Eric Yoshida
Body Locations and Systems
Liver Diseases
Area
Vancouver
Age
18-85

A Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic HBV (ACHEIVE)

This is a Phase 2, open-label,randomized, multiple dose, varied administration regimen study with 2 parts (Parts A and B) in Subjects Infected with Chronic Hepatitis B Virus

Status
Recruiting
Principal Investigator
Eric Yoshida
Body Locations and Systems
Hepatitis B
Area
Vancouver
Age
18-70

Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis (UCanADA)

To evaluate the real-life effect of adalimumab on psychological distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients. 

Status
Recruiting
Principal Investigator
Baljinder Salh
Body Locations and Systems
Ulcerative Colitis
Area
Vancouver
Age
18-99

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

Status
Recruiting
Principal Investigator
Baljinder Salh
Body Locations and Systems
Ulcerative Colitis
Area
Vancouver
Age
18-75

Durability of Virologic Response and/or Viral Resistance Patterns in Participants With Chronic Hepatitis C Who Have Been Previously Treated With Grazoprevir (MK-5172) (MK-5172-017)

This three-year study (participants with chronic kidney disease [CKD] or cirrhosis will be followed for five years) multicenter study is being done to follow participants who received at least one dose of grazoprevir (MK-5172) in a previous study to determine if they remain hepatitis C virus (HCV)-RNA negative over time, and to determine if they have developed antiviral resistance. The study will also evaluate long-term adverse events in this population.

Status
Recruiting
Principal Investigator
Eric Yoshida
Body Locations and Systems
Hepatitis C
Area
Vancouver
Age
18 and above

Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's Patients

Hospitalization for kidney stones in the Inflammatory Bowel Disease (IBD) population is common, particularly among Crohn's patients who had a small bowel resection. This patient population experiences a lifetime occurrence of kidney stone formation as high as 25% accompanied with a high rate of recurrence (the typical rate of stone formation is ~10% in the non IBD population). Giving oral calcium is used to bind oxalate in the intestine in an attempt to reduce the amount of oxalate that is absorbed into the body and to reduce urinary oxalate levels.

Status
Recruiting
Principal Investigator
Ben Chew
Body Locations and Systems
Kidney Stones
Crohn's Disease
Area
Vancouver
Age
19 and above

Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay (HBVQuant)

This non-interventional clinical study will be conducted to prospectively collect serial plasma samples from subjects with chronic HBV infection who are initiating antiviral therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HBV Quant assay, which is used as an aid in the management of HBV-infected patients undergoing HBV antiviral therapy.

Status
Recruiting
Principal Investigator
Peter W.C. Kwan
Body Locations and Systems
Hepatitis B
Area
Vancouver
Age
18 and above

A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.


 

Status
Recruiting
Principal Investigator
Baljinder Salh
Body Locations and Systems
Ulcerative Colitis
Area
Vancouver
Age
18-99

Gilead Sustained Virologic Response (SVR) Registry

This Registry is designed to provide long term clinical and virologic follow up in subjects who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored Hepatitis C Virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.

Status
Recruiting
Principal Investigator
Eric Yoshida
Body Locations and Systems
Hepatitis C
Area
Vancouver
Age
18 and above

Closed for Recruitment

A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects With Crohn's Disease

This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of ABT-494.

Status
Closed for Recruitment
Principal Investigator
Baljinder Salh
Body Locations and Systems
Crohn's Disease
Area
Vancouver
Age
18-75

Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) (RESOLVE-IT)

The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

Status
Closed for Recruitment
Principal Investigator
Eric Yoshida
Body Locations and Systems
Liver Diseases
Area
Vancouver
Age
18-75

Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

This study is a clinical research study to see if the investigational medication, GED-0301, is effective in participants with active Crohn’s disease. GED-0301 (mongersen) is a drug taken by mouth that inhibits an immune response in the gut (Smad 7) that causes inflammation (or swelling). 

Status
Closed for Recruitment
Principal Investigator
Baljinder Salh
Body Locations and Systems
Crohn's Disease
Area
Vancouver
Age
18 and above

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