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Research & Clinical Trials

Open Research & Clinical Trials

All of our physicians participate in research and open clinical trials, be sure and check back in periodically this list is updated monthly. Currently we are conducting trials for the following disorders:.

ULCERATIVE COLITIS:

 

Recepts-RPC1063-Male or female 18-75 years old with moderate to severe UC. Currently taking an aminosalicylate, prednisone 20mg or less, or budesonide. Patients will have up to 4 colonoscopies over 9 months. Induction period of 10 weeks...If they do well they can enter maintenance for 5 months to eventually enter an open label study for 72 weeks or until FDA approval.

(Wofford/Amie) Receptos- RPC1063- Open label- complete first study and receive meds until 2020

Patient Reimbursement

$1,400

NASH/FATTY LIVER/CIRRHOSIS:

 

Lifesciences- Blood draw study only. NASH arm is closed. Fatty liver must have had a biopsy in the past 3 yrs. 1 lab draw.

(Knapple/Kenny)

Patient Reimbursement

$50

Intercept-Obeticholic Acid- NASH with fibrosis 2/3. Does not have to have confirmed NASH prior to screening. Will have 4 liver biopies in 6 years and app 13 hepatobilary ultrasounds. No current significant alcohol consumption. No Hep b/c on confirmed cirrhosis.

(Knapple/Amie)

Patient Reimbursement up to

$2,500

Intercept- Cirrhosis-Obeticholic Acid- NASH F4. Will pay for liver biopsy or can use a previous one within the 12 months. 12 months double blind then option for open label for 24 months. 3 liver biopsies total.

(Knapple/Amie)

Patient Reimbursement up to

$75 (per visit)

$50 (per per ultrasound and fibroscan)
$500 (per liver biopsy)

Gilead-Selonsertib-NASH F3 or F4. compensated cirrhosis. 18-70 yrs old, male and female. Can last up to 252 weeks. Patient will have 3 liver biopsies.

(Murphy/Kenny)

Patient Reimbursement up to

$75 (per visit)

$50 (per per ultrasound)
$125 (per liver biopsy)

Cirius Therapuetics-(MSDC-0602K) NASH F1, F2 oor F3. 18 yrs or older, 12 month study. 2 liver biopsies. BMI 50. Females cannot be of childbearing potential. Current use of insulin or glizitones are exclusionary. 9 visits.

(Knapple/Kenny)

Patient Reimbursement

$75 (per visit)

$250 (per liver biopsy)

VACCINE:

 

Pfizer-Cdiff Vaccine- Male or female 50 yrs or older. At least 1 inpatient (2 night) hospitalization, or 2 ER visits, or 10 outpatient visits in the past 12 months or antibiotic treatment in the past 12 weeks. 3 vaccine injections...5 visits over 7 months.

(Wofford/Amie/Steph)

Patient Reimbursement

$75 (per visit)

EOSINOPHILIC ESOPHAGITIS:

 

Adare Pharmaceuticals-APT-1011 Fluticasone orally disintgrating tablet- Male and female 18 yrs or older. 52 weeks participation-4 EGDs. Must be on BID PPI dose for 8 weeks prior to screening and have at least 15 eosinophils.

(Wofford/Steph)

Patient Reimbursement

$125 (per visit...from 6-12 visits total)

STOOL STUDIES:

 

Diasorin-fecal calprotectin study- Male or female 22 yrs old. Patient being evaluated by a physician for the investigation of a GI disorder (abd pain, altered appetite, weight loss or anemia) that will be undergoing a colonoscopy for diagnosis. Patient to collect stool sample prior to colon prep-no PPI, NSAID, or steroids within 7 days.

(Murphy/Steph)

Patient Reimbursement

$50 (colonoscopies are not paid for)

HEPATITIS C:

 

Abbvie-Glecaprevir/Pibrentasvir- Male or female 18 yrs or older. Treatment naive. Any genotype allowed. Positive for at least 6 months with no cirrhosis.

(Knapple/Kenny)

CDIFF:

 

Sere-Eubacterial Spore (Purified suspension, encapsulated)-  Male or female 18 yrs or older. History of 3 or more CDI episodes in the past 9 months (including current episode with positive toxin assay) SOC antibiotic treatment with 10-21 days of vanc or fidoxomicin. Placebo based-if patient has reaccurrance after treatment-can roll over into open label study for another treatment. 24 week study.

(Wofford/Amie)

Patient Reimbursement

$84 (per visit X 7)

Rebiotix-fecal transplant- Male or female 18 yrs or older. 2 previous cdiff episodes plus current episode. Will complete antibiotic treatment (including flagyl) and will have 1 enema (placebo or study transplant) If patient recurrs within 8 weeks, will have another study transplant.

(Knapple/Kenny)

Patient Reimbursement

$50 (per visit)

HPYLORI:

 

Redhill-(rifabutin150mg, amoxicillin 3000mg, omeprazole120mg VS. amoxicillin 3000mg, omeprazole 120mg)  Male and female 18-70 yrs old. No history of hpylori tx. Symptoms consistant with dyspepsia for at least 2 weeks. No PPI for 2 weeks prior to screening. Once screened with positive breath test-will have EGD for CLO, C&S and histology. If FU breath test is positive-will treat with SOC.

(Barton/Steph)

Patient Reimbursement

$75 (per visit X 4)

$150 (per EGD-1 to 2)

$100 (breath test)

COLON PREP:

 

Braintree-(BLI4700-24 tablets split dosing VS. Prepopik split dosing)- Male and female 18-85 yrs old. Patient
will have routine colonoscopy for screening or diagnostic purposes. No IBD. No insulin use. 2 clinic visits and 1 colonoscopy
(unless lab abnormalities on day after colonoscopy). Investigator blinded. 3 patients per doctor as we initially have 25 slot for our site.

(Fernandez/Kenny)

Patient Reimbursement

$375

DIABETIC GASTROPARESIS:

 

Allergan-(Relamoralin)- Male and female 18-75 yrs old...must be diabetic.BMI 35. Will have breath test for confirmation. SQ injection bid. Patients will have 7 visits.

(Murphy/Steph)

Patient Reimbursement

$750


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