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Clinical Trials

Hepatitis C Testing

Starting April 2012, we are doing Hepatitis C Antibody Testing!  Who should be tested? http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6104a1.htm?s_cid=rr6104a1_w  The cost is $25 (cash or check) and the results will be back within 24-48 business hours.  All testing is confidential.

Crohn's Disease

Takeda Pharmaceuticals is conducting a clinical research study evaluating people who have Crohn's disease.  The purpose of this study is to learn more about the effectiveness and safety of vedolizumab subcutaneous (SC) injection compared to placebo SC injection in people with moderately to severely active Crohn's disease.

Upon completion of this clinical research study, you may be eligible to participate in the vedolizumab Open Label Extension study.

For more information, call us at 918-513-3490. 

 

IBS

All types of IBS. Open label, single-arm, multi-center, interventional study in the US, to evaluate the potential of fuco-N-tetraose to support normal bowel habits in adults with IBS under "real world" conditions, 12 week treatment + monthly questionnaires.

Crohn's Disease

Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn's Disease.

 

  • 6 month diagnosis with involvement of the ilieum and/or colon
  • Stable dose of 5-ASA or 6-MP or Predisone for at least 4 weeks prior to randomization
  • Cannot have current complications of strictures, fistulae, or short bowel syndrome

 

Ulcerative Colitis

Placebo controlled study to evaluate the safety of a drug compared to placebo for induction and maintenance therapy with Moderate to severe UC. This is a JAK Inhibitor, which is an oral compound.

 

Nash

Oral daily dosing for subjects with NASH Fibrosis, not cirrhosis.  Fibroscan will be performed.  72 week treatment period and additional double-blind long term treatment for up to 3 additional years.

 Inclusion criteria:

  • Age 18 to 75
  • BMI <45kg
  • Liver Biopsy with steatosis score of 0-3 
  • NAS score of >4
  • Fibrosis stage of 1 or greater and below 4.
Please click on the link for more information:  http://www.resolve-it-nash-study.com/#/
 
Patients must meet all of the following inclusion criteria to be eligible for enrollment in the 
trial:
1.  Males or females aged from 18 to 75 years inclusive at first Screening Visit.
2.  Must provide signed written informed consent and agree to comply with the study protocol.
 3.  Body Mass Index ≤45 kg/m².

Clinical Trial ELAFIBRANOR-315-1
 Protocol V1.0 15Jan2016
GENFIT                                                        CONFIDENTIAL                          
                   Page 9 of 129
4. Females participating in the study must either not be of childbearing potential (hysterectomy, 
bilateral oophorectomy, medically documented ovarian failure, or >50 years of age with cessation of 
menses for at least 12 months due to ovarian failure) or using efficient double contraception: 
hormonal contraception (including patch, contraceptive ring, etc), intra-uterine device, or other 
mechanical contraception method + condom or diaphragm or spermicide for the full duration of the 
study and for 1 month after the end of treatment.
5. Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of 
the slides (biopsy obtained within 6 months prior to Randomization or during the Screening Period) 
with at least 1 in each component of the NAS score (steatosis scored 0-3, ballooning degeneration 
scored 0-2, and lobular inflammation scored 0-3).
6.  NAS score ≥4.
7.  Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
For patients with fibrosis stage 1, only patients at high risk of progression will be included 
meaning with a NAS score ≥5 and 2 of the following conditions: persistent elevated ALT, obesity 
defined by a BMI 30, metabolic syndrome (NCEP ATP III definition), type 2 diabetes, or HOMA-IR >6.
8. Patients agree to have 1 liver biopsy during the Screening Period for diagnostic purpose (if no 
historical biopsy within 6 months before Randomization is available), 1 liver biopsy after 72-weeks 
of treatment for assessment of the treatment effects on NASH, as well as another in case of 
suspicion of cirrhosis (to have a histological confirmation), and a final liver biopsy after 
approximately 4 years of treatment (visit V13), unless a biopsy has already been performed within 
the year.
9. Stable dose of vitamin E (>400 IU/day), polyunsaturated fatty acids (>2 g/day), or 
ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy.
10. For patients with type 2 diabetes, glycemia must be controlled. If glycemia is controlled by 
antidiabetic drugs, no change in anti-diabetic therapy is allowed within 6 months prior to 
diagnostic liver biopsy, under the following conditions:
o no change in dose for patients treated by glucagon-like peptide 1 agonist
o no qualitative change (i.e. implementation of a new anti-diabetic drug) for patients treated by 
metformin, dipeptidyl-peptidase 4 inhibitors, sodium/glucose cotransporter 2 inhibitors,
sulfamides, or insulin.
Inclusion criteria:
Patients must meet all of the following inclusion criteria to be eligible for enrollment in the 
trial:
1.  Males or females aged from 18 to 75 years inclusive at first Screening Visit.
2.  Must provide signed written informed consent and agree to comply with the study protocol.
 3.  Body Mass Index ≤45 kg/m².

Clinical Trial ELAFIBRANOR-315-1
 Protocol V1.0 15Jan2016
GENFIT                                                        CONFIDENTIAL                          
                   Page 9 of 129
4. Females participating in the study must either not be of childbearing potential (hysterectomy, 
bilateral oophorectomy, medically documented ovarian failure, or >50 years of age with cessation of 
menses for at least 12 months due to ovarian failure) or using efficient double contraception: 
hormonal contraception (including patch, contraceptive ring, etc), intra-uterine device, or other 
mechanical contraception method + condom or diaphragm or spermicide for the full duration of the 
study and for 1 month after the end of treatment.
5. Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of 
the slides (biopsy obtained within 6 months prior to Randomization or during the Screening Period) 
with at least 1 in each component of the NAS score (steatosis scored 0-3, ballooning degeneration 
scored 0-2, and lobular inflammation scored 0-3).
6.  NAS score ≥4.
7.  Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
For patients with fibrosis stage 1, only patients at high risk of progression will be included 
meaning with a NAS score ≥5 and 2 of the following conditions: persistent elevated ALT, obesity 
defined by a BMI 30, metabolic syndrome (NCEP ATP III definition), type 2 diabetes, or HOMA-IR >6.
8. Patients agree to have 1 liver biopsy during the Screening Period for diagnostic purpose (if no 
historical biopsy within 6 months before Randomization is available), 1 liver biopsy after 72-weeks 
of treatment for assessment of the treatment effects on NASH, as well as another in case of 
suspicion of cirrhosis (to have a histological confirmation), and a final liver biopsy after 
approximately 4 years of treatment (visit V13), unless a biopsy has already been performed within 
the year.
9. Stable dose of vitamin E (>400 IU/day), polyunsaturated fatty acids (>2 g/day), or 
ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy.
10. For patients with type 2 diabetes, glycemia must be controlled. If glycemia is controlled by 
antidiabetic drugs, no change in anti-diabetic therapy is allowed within 6 months prior to 
diagnostic liver biopsy, under the following conditions:
o no change in dose for patients treated by glucagon-like peptide 1 agonist
o no qualitative change (i.e. implementation of a new anti-diabetic drug) for patients treated by 
metformin, dipeptidyl-peptidase 4 inhibitors, sodium/glucose cotransporter 2 inhibitors,
sulfamides, or insulin.
Inclusion criteria:
Patients must meet all of the following inclusion criteria to be eligible for enrollment in the 
trial:
1.  Males or females aged from 18 to 75 years inclusive at first Screening Visit.
2.  Must provide signed written informed consent and agree to comply with the study protocol.
 3.  Body Mass Index ≤45 kg/m².

Clinical Trial ELAFIBRANOR-315-1
 Protocol V1.0 15Jan2016
GENFIT                                                        CONFIDENTIAL                          
                   Page 9 of 129
4. Females participating in the study must either not be of childbearing potential (hysterectomy, 
bilateral oophorectomy, medically documented ovarian failure, or >50 years of age with cessation of 
menses for at least 12 months due to ovarian failure) or using efficient double contraception: 
hormonal contraception (including patch, contraceptive ring, etc), intra-uterine device, or other 
mechanical contraception method + condom or diaphragm or spermicide for the full duration of the 
study and for 1 month after the end of treatment.
5. Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of 
the slides (biopsy obtained within 6 months prior to Randomization or during the Screening Period) 
with at least 1 in each component of the NAS score (steatosis scored 0-3, ballooning degeneration 
scored 0-2, and lobular inflammation scored 0-3).
6.  NAS score ≥4.
7.  Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
For patients with fibrosis stage 1, only patients at high risk of progression will be included 
meaning with a NAS score ≥5 and 2 of the following conditions: persistent elevated ALT, obesity 
defined by a BMI 30, metabolic syndrome (NCEP ATP III definition), type 2 diabetes, or HOMA-IR >6.
8. Patients agree to have 1 liver biopsy during the Screening Period for diagnostic purpose (if no 
historical biopsy within 6 months before Randomization is available), 1 liver biopsy after 72-weeks 
of treatment for assessment of the treatment effects on NASH, as well as another in case of 
suspicion of cirrhosis (to have a histological confirmation), and a final liver biopsy after 
approximately 4 years of treatment (visit V13), unless a biopsy has already been performed within 
the year.
9. Stable dose of vitamin E (>400 IU/day), polyunsaturated fatty acids (>2 g/day), or 
ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy.
10. For patients with type 2 diabetes, glycemia must be controlled. If glycemia is controlled by 
antidiabetic drugs, no change in anti-diabetic therapy is allowed within 6 months prior to 
diagnostic liver biopsy, under the following conditions:
o no change in dose for patients treated by glucagon-like peptide 1 agonist
o no qualitative change (i.e. implementation of a new anti-diabetic drug) for patients treated by 
metformin, dipeptidyl-peptidase 4 inhibitors, sodium/glucose cotransporter 2 inhibitors,
sulfamides, or insulin.
Inclusion criteria:
Patients must meet all of the following inclusion criteria to be eligible for enrollment in the 
trial:
1.  Males or females aged from 18 to 75 years inclusive at first Screening Visit.
2.  Must provide signed written informed consent and agree to comply with the study protocol.
 3.  Body Mass Index ≤45 kg/m².

Clinical Trial ELAFIBRANOR-315-1
 Protocol V1.0 15Jan2016
GENFIT                                                        CONFIDENTIAL                          
                   Page 9 of 129
4. Females participating in the study must either not be of childbearing potential (hysterectomy, 
bilateral oophorectomy, medically documented ovarian failure, or >50 years of age with cessation of 
menses for at least 12 months due to ovarian failure) or using efficient double contraception: 
hormonal contraception (including patch, contraceptive ring, etc), intra-uterine device, or other 
mechanical contraception method + condom or diaphragm or spermicide for the full duration of the 
study and for 1 month after the end of treatment.
5. Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of 
the slides (biopsy obtained within 6 months prior to Randomization or during the Screening Period) 
with at least 1 in each component of the NAS score (steatosis scored 0-3, ballooning degeneration 
scored 0-2, and lobular inflammation scored 0-3).
6.  NAS score ≥4.
7.  Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
For patients with fibrosis stage 1, only patients at high risk of progression will be included 
meaning with a NAS score ≥5 and 2 of the following conditions: persistent elevated ALT, obesity 
defined by a BMI 30, metabolic syndrome (NCEP ATP III definition), type 2 diabetes, or HOMA-IR >6.
8. Patients agree to have 1 liver biopsy during the Screening Period for diagnostic purpose (if no 
historical biopsy within 6 months before Randomization is available), 1 liver biopsy after 72-weeks 
of treatment for assessment of the treatment effects on NASH, as well as another in case of 
suspicion of cirrhosis (to have a histological confirmation), and a final liver biopsy after 
approximately 4 years of treatment (visit V13), unless a biopsy has already been performed within 
the year.
9. Stable dose of vitamin E (>400 IU/day), polyunsaturated fatty acids (>2 g/day), or 
ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy.
10. For patients with type 2 diabetes, glycemia must be controlled. If glycemia is controlled by 
antidiabetic drugs, no change in anti-diabetic therapy is allowed within 6 months prior to 
diagnostic liver biopsy, under the following conditions:
o no change in dose for patients treated by glucagon-like peptide 1 agonist
o no qualitative change (i.e. implementation of a new anti-diabetic drug) for patients treated by 
metformin, dipeptidyl-peptidase 4 inhibitors, sodium/glucose cotransporter 2 inhibitors,
sulfamides, or insulin.Ag

NASH

Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Cenicriviroc "CVC" for the treatment of liver Fibrosis (F2-F3) in adults with NASH.

 

  • 6 year treatment phase
  • 2-3 liver biopsies during the course of the study 

 

Gastroparesis

Phase 2, multicenter, randomized, double-blind, placebo controlled proof of concept study to assess the efficacy of 
Tradipitant in relieving symptoms of gastroparesis, 4 wk study, idiopathic or diabetic, FOCUSING ON NAUSEA.

Gastroparesis

Phase 3, 12 week, randomized, double-blind, placebo-controlled trial with a 4-week randomized-withdrawal period to evaluate the safety and efficacy of Relamorelin in participants with Diabetic Gastroparesis, injectable

NASH-Decompensated

Phase 2b, multicenter, randomized, double-blind, placebo-controlled trial of Emricasan, an Oral Caspase Inhibitor, in subject with Decompensated "NASH" Cirrhosis. 48 week treatment arm, BID oral dosing, CT/MRI performed, NO Liver Biopsies