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NCT ID: NCT02094222 No longer available - Byler Disease Clinical Trials

Expanded Access Protocol for an Intermediate Size Population - RAVICTI for Byler Disease

Start date: n/a
Phase:
Study type: Expanded Access

Byler Disease is the result of a homozygous missense (G308V) mutation in the ATP8B1 gene. The disease is typically manifest in the first year of life on the basis of complications of cholestasis; common presentations include jaundice, poor growth, bleeding related to vitamin K deficiency, and/or weak bones related to vitamin D deficiency. Early management of Byler Disease is directed at nutritional issues which tend to be responsive to medical intervention, unlike the pruritus/scratching which remains a devastating problem. Progressive liver disease develops in Byler Disease and can lead to cirrhosis and end-stage liver disease. This is an open label expanded access protocol of RAVICTI in children with Byler Disease. The primary hypothesis is that the administration of RAVICTI in these children is feasible, well tolerated and safe. It is also hypothesized that RAVICTI treatment leads to an improvement in biochemical markers of liver disease and it may ameliorates or prevents the development of scratching behavior as a manifestation of pruritus attributed to the liver disease.

NCT ID: NCT02097251 No longer available - Clinical trials for Mucopolysaccharidosis Type 7

An Open-Label Treatment Protocol With UX003 rhGUS Enzyme Replacement Therapy for an Advanced Stage MPS 7 Patient

Start date: n/a
Phase: N/A
Study type: Expanded Access

Emergency access granted to treat a single patient with advanced Mucopolysaccharidosis Type 7 with UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy via IV administration every other week (QOW) for up to 144 weeks.

NCT ID: NCT02097966 No longer available - Chronic Hepatitis C Clinical Trials

EU: A Multicenter Compassionate Use Program of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C

Start date: n/a
Phase: N/A
Study type: Expanded Access

The primary objective of this program is to provide Daclatasvir in combination with Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options.

NCT ID: NCT02121769 No longer available - Clinical trials for Parenteral Nutrition Associated Liver Disease

Omegaven Expanded Access Protocol

Start date: n/a
Phase:
Study type: Expanded Access

Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.

NCT ID: NCT02142868 No longer available - Clinical trials for Advanced Breast Cancer (Female)

Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

Start date: n/a
Phase:
Study type: Expanded Access

To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line patients only).

NCT ID: NCT02147951 No longer available - Clinical trials for Unresected Stage IIIb to IVM1c Melanoma

Expanded Access Protocol of Talimogene Laherparepvec for Subjects With Unresected, Stage lllB to IVM1c Melanoma

Start date: n/a
Phase: Phase 3
Study type: Expanded Access

Expanded access of Talimogene Laherparepvec for subjects with unresected, stage IIIb to IVM1c Melanoma.

NCT ID: NCT02148146 No longer available - Cholestasis Clinical Trials

Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis

Start date: n/a
Phase:
Study type: Expanded Access

This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition.

NCT ID: NCT02161939 No longer available - Chronic Hepatitis C Clinical Trials

A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Post-Liver Transplant Subjects With Chronic Hepatitis C

Start date: n/a
Phase: N/A
Study type: Expanded Access

The primary objective of this program is to provide DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C recurrence with either advanced fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to <12 months, therefore, no research hypothesis will be tested and no specific endpoints are defined. However, safety data will be collected throughout the study as well as efficacy data

NCT ID: NCT02174679 No longer available - Clinical trials for Neuroendocrine Tumors

68Ga DOTATATE PET/CT in Neuroendocrine Tumors (Expanded Access)

Start date: n/a
Phase:
Study type: Expanded Access

To evaluate 68Ga-DOTATATE PET/CT for staging of patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.

NCT ID: NCT02178202 No longer available - Low Back Pain Clinical Trials

McKenzie Exercise Vs Harmonic Technique in Chronic Low Back Pain

CLBP
Start date: n/a
Phase: N/A
Study type: Expanded Access

The purpose of this study was to investigate the effects of HT compared with McK exercise on pain and disability in patients with LBP.