Current Clinical Trials

ABERRA:
Purpose:
A medical research study in adult patients who have moderate to severe Crohns disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohns disease.

Study Type: Interventional

Study Design:
Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Official Title:
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohns Disease Previously Treated With TNF Antagonist Therapy

Primary Outcome Measures:

To evaluate the clinical response of ustekinumab vs placebo at Week 6 as measured by the reduction from baseline in CDAI.

Secondary Outcome Measures:

To evaluate the efficacy of ustikenumab in inducing clinical remission, fistula response and mucosal healing and to obtain data to support the selection of a maintenance dose for continued clinical development.

Detailed Description:
In Crohns disease there is inflammation (changes in body tissue which normally happen during injury or infection) and or ulceration (open sores) in the intestines. This occurs because the immune system (the part of the body that fights off infection) has an abnormal and overactive response against the intestine and bowel tissues of the body. Crohns disease is usually treated with medications that either directly decrease inflammation or decrease the general activity of the immune system to improve the diarrhea, abdominal pain, and other symptoms of Crohns Disease. Ustekinumab antibodies (natural substances made by your immune system to stick to and help remove foreign materials in your body that cause diseases) have been created to stick to and block the activity of two of the immune substances thought to cause abnormal inflammation of Crohns disease. Patients who are eligible and who have received Remicade, Humira, or Cimzia and failed or been intolerant to one of these drugs will be randomized to either active drug (ustekinumab) or placebo. All patients will be randomized (like flipping a coin) at week 0 to be in one of 4 groups. At week 0 the study drug will be given by IV administration and at weeks 8 and 16 by subcutaneous injection. There will be 11 study visits in total and the study will continue until week 36. Blood and stool samples will be collected and studied, questionnaires to check on how you are doing in terms of your disease will be completed, an Electrocardiogram (EKG) obtained, safety evaluations conducted and diary cards distributed to be completed during the entire study.

One of 4 groups: Grp 1-placebo, Grp 2-active drug 1mg/kg IV, Grp 3-active drug 3mg/kg IV, Grp 4-active drug 6mg/kg IV. Based on the clinical response status at Week 6, patients from Grps 2, 3 and 4 will be re-randomized at week 8 to receive either placebo or 90 mg SC at both weeks 8 and 16 and patients from Grp 1 will receive placebo at Week 8 and Week 16 or a 270 mg SC injection at Week 8 and 90 mg SC at Week 16.

Eligibility: Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

Must have Crohn's disease or fistulizing Crohn's disease of at least 3 months duration
Must have received Remicade, adalimumab or Cimzia at a dose approved for the treatment of Crohn's disease
Must have failed or been intolerant to Remicade, Humira or Cimzia for treatment of Crohn's disease
Must be 18 years of age or older
Must have active Crohn's disease according to the Crohn's Disease Activity Index (CDAI > =220 and < =450)

Exclusion Criteria:

Patients who have had any kind of bowel resection, diversions or placement of a stoma within 6 months
Are pregnant, nursing or planning pregnancy (both men and women) while enrolled in the study or within 1 year after receiving study agent
Patients who have received Remicade, Humira or Cimzia < =8 weeks before the first administration of study drug
Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug
Patients with a history of or ongoing chronic or recurrent infectious disease

Contact: University of Pennsylvania
Philadelphia, PA 19104
Research Coordinator: Julie Starr 215-573-1865
Principal Investigator: Faten Aberra, MD

METZ

Purpose:
The purpose of this study is to determine whether monthly injections of Somatuline Depot are effective and safe in controlling diarrhea and flushing in patients with carcinoid syndrome.

Study Design:
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title: A Double-Blind, Randomized Placebo-Controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome

Primary Outcome Measures:

Usage of subcutaneous octreotide required to control symptoms associated with carcinoid syndrome, during the 16-week double-blind phase of the study based on patient IVRS diary records

Eligibility: Ages Eligible for Study: 18 - 75 years old
Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Inclusion Criteria:

histopathologically confirmed diagnosis of carcinoid tumor
history of carcinoid syndrome (flushing and/or diarrhea)
either naive to treatment with a Somatostatin analog or responsive to conventional doses of LAR or subcutaneous octreotide
confirmation of positive somatostatin receptor status by somatostatin receptor scintigraphy
absence of tumor progression

Exclusion Criteria:

history of carcinoid syndrome refractory to treatment with conventional doses of Somatostatin analogs
treatment with interferon, chemotherapy and/or radiotherapy, a radiolabelled Somatostatin analog and/or tumor debulking < 3 months prior to study entry
history of hepatic arterial embolization
short bowel syndrome
uncontrolled diabetes and/or hypertension
severe renal impairment and/or liver impairment
diagnosis of cardiac disease

Contact:                                                                                                                                                                    University of Pennsylvania
Philadelphia, PA 19104
Research Coordinator: Julie Starr 215-573-1865                  Principal Investigator: David Metz, MD

ADVANCE (CLOSED TO ENROLLMENT)
Contact: Grace Kim-Lee 215-898-3981

        A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination with Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects with Genotype 1 Chronic Hepatitis C

SyNCH II (Hepatitis C)
Contact: Amy Micheli 215-898-2450 Email

       A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase II Study to Assess the Safety and Efficacy of a Standardized Orally Administered Silymarin Preparation (Legalon) for the Treatment of Non-Cirrhotic Patients with Chronic Hepatitis C Who Failed Conventional Antiviral Therapy

SyNCH II (NASH)
Contact: Amy Micheli 215-898-2450 Email

     A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Phase II Study to Assess the Safety and Efficacy of a Standardized Orally Administered Silymarin Preparation (Legalon) for the Treatment of Non-Cirrhotic Patients with Non-Alcoholic Steatohepatitis

ProPeach (CLOSED TO ENROLLMENT)
Contact: Amy Micheli 215-898-2450

        A Multiple-Center, Observer-Blinded, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Food Effect of RO5024048 in Healthy Volunteers and in Patients with Chronic HCV Infection of Genotype 1

Enable 1
Contact: Amy Micheli 215-898-2450 Email

Randomized, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects with Hepatitis C Virus (HCV) Infection who are Otherwise Eligible to Initiate Antiviral Therapy (peginterferon alfa-2a plus ribavirin)

Enable 2
Contact: Amy Micheli 215-898-2450 Email

Medarex (CLOSED TO ENROLLMENT)
Contact: Jamie Perry 215-898-0187

A phase I, double-blind,randomized, placebo-controlled, safety and pharmacokinetic dose-escalation study of a single intravenous administration of MDX-1106, a fully human monoclonal antibody to PD-a, in subjects with active hepatitis C genotype 1 infection

DILIN (Prospective arm)
Contact: Amina Wirjosemito 215-615-5471 Email

Continuation and expansion of the drug induced liver injury network for patients who have suffered liver injury from drugs or complimentary and alternative medicines in the past 6 months.

DILIN (Retrospective arm)
Contact: Amina Wirjosemito 215-615-5471 Email

Continuation and expansion of the drug induced liver injury network for patients who have suffered liver injury from isoniazid (INH), phenytoin (Dilantin), combination clavulanic acid/amoxicillin (Augmentin), and valproic acid (Depakote), Nitrofurantoin, Trimethoprim-sulfamethoxazole, Minocycline, and Quinolone antibiotics since January 1, 1994.

Acute Liver Failure
Contact: Amina Wirjosemito 215-615-5471 Email

A multi center group to study acute liver failure

Acute Liver Injury
Contact: Amina Wirjosemito 215-615-5471 Email

A multi center group to study acute liver failure

Exalenz
Contact: Amina Wirjosemito 215-615-5471 Email

A pivpta; study assessing the efficacy and safety of the BreathIS system for detection of cirrhosis

Boehringer Ingelheim
Contact: Amy Micheli 215-898-2450 Email

Antiviral effect, safety and pharmacokinetics of BL 201335 NA in hepatitis C virus genotype 1 infected treatment-naïve and treatment-experienced patients as combination therapy with pegylated interferon-alpha 2a and ribavirin (double-blinded, randomized, placebo-controlled phase II)

Gilead 227-0106
Contact: Amy Micheli 215-898-2450 Email

A Phase 2b, Double0-blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of GS-9450 in Adults with Chronic Hepatitis C Virus Infectioin

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Current Clinical Trials