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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR POLYETHYLENE GLYCOL 3350

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Clinical Trials for Polyethylene Glycol 3350

Trial ID Title Status Sponsor Phase Summary
NCT00001410 PEG-Glucocerebrosidase for the Treatment of Gaucher Disease Completed National Institute of Mental Health (NIMH) Phase 1 Gaucher disease is a lysosomal storage disease resulting from glucocerebroside accumulation in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase. It may occur in patients of all ages. The condition is marked by enlargement of the liver and spleen (hepatosplenomegaly), low blood and platelet counts, and bone abnormalities. The condition is passed from generation to generation on via autosomal recessive inheritance. There are actually three types of Gaucher disease. Type I is the most common form. It is a chronic non-neuronopathic form, meaning the disease does not affect the nervous system. The symptoms of type I can appear at any age. Type 2 Gaucher disease presents prenatally or in infancy and usually results in death for the patient. Type 2 is an acute neuronopathic form and can affect the brain stem. It is the most severe form of the disease. Type 3 Gaucher disease is also neuronopathic, however it is subacute in nature. This means the course of the illness lies somewhere between long-term (chronic) and short-term (acute). Currently there is not a cure for Gaucher disease. Treatment for the disease has traditionally been supportive. In some severely affected patients, bone-marrow transplants have corrected the enzyme deficiency, but it is considered a high-risk procedure and recovery can be very slow. Enzyme replacement therapy is another therapy option and has been approved by the Food and Drug Administration (FDA) for use in type 1 patients. PEG-glucocerbrosidase is a drug designed to clear out the accumulation of lipid (glucocerebroside) from the blood stream. The drug is actually an enzyme attached to large molecules called polyethylene glycol (PEG). The large molecules of PEG allow the enzyme to remain in the blood stream for long periods of time. By modifying glucocerebrosidase with PEG, it is believed that smaller doses will be required, meaning a reduction in cost for the patient and more convenient administration of the drug. The purpose of this study is to evaluate the effects and safety of enzyme replacement therapy using PEG- glucocerebrosidase for the treatment of Gaucher disease.
NCT00004695 Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency Completed Icahn School of Medicine at Mount Sinai N/A OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency. II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.
NCT00018031 Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 This study will evaluate the safety and effectiveness of combination therapy with peginterferon alfa-2b and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. In studies of patients with hepatitis C alone, interferon alfa-2b plus ribavirin treatment eradicated the HCV in almost half the patients. Peginterferon alfa-2b is a compound that results from attaching a polyethylene glycol molecule to interferon alfa-2b. This compound stays in the blood longer than unmodified interferon alfa-2b, causing a higher blood concentration and thus maintaining activity against the hepatitis C virus. HIV-infected patients 21 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copies/mL may be eligible for this 2 1/2-year study. Candidates will be screened with blood and urine tests and possibly a liver biopsy, if a recent one is not available. The liver biopsy is done to determine the severity of liver disease. For this test, patients are admitted to the NIH Clinical Center for 1 to 2 days. A sedative is injected into an arm vein, the skin in the area over the biopsy site is numbed with a local anesthetic, and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample. The patient remains in the hospital overnight for monitoring. A chest X-ray, electrocardiogram (EKG) and liver ultrasound are also done. Within 4 weeks of the screening tests, candidates who appear eligible for the study will have a physical examination, medical history and repeat blood tests. Women who can become pregnant will have serial pregnancy tests throughout the study. Patients who meet the study criteria and decide to participate will begin treatment with weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a day by mouth. In addition, patients will continue to take all other medications prescribed by their doctor. Clinic visits will be scheduled as follows: - Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV. - Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56 and 64 - Blood and urine tests will be done to determine the side effects of treatment and its effect on the HCV infection. - Week 48 or end of treatment - Treatment will stop after 48 weeks. At this time, or earlier for those who do not complete the 48 weeks, patients will return to the clinic for a routine test.
NCT00029900 ADI-PEG in Patients With Metastatic Melanoma Completed FDA Office of Orphan Products Development Phase 1 This is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic melanoma.
NCT00056992 Testing of ADI-PEG in Hepatocellular Carcinoma Completed FDA Office of Orphan Products Development Phase 2 Amino acid deprivation therapy is an effective means for the treatment of some forms of cancer. Recently it has been found that human hepatocellular carcinomas (HCC) cell lines appear to require arginine for growth. Arginine is not an essential amino acid for human adults or infants as it can be synthesized from citrulline (for review see Rogers 1994). Therefore, selective elimination of arginine from the circulation may be a means of treating patients with metastatic melanoma or non resectable HCC. The enzyme arginine deiminase (ADI) metabolizes arginine into citrulline (Cunin 1986). However, ADI is only found in microbes and not in humans. ADI is therefore, highly immunogenic and has a short serum half-life following injection. These potential drawbacks (microbial source and thus viewed as foreign by the human immune system, and a short serum half-life) can be overcome by covalent attachment of polyethylene glycol (PEG) to argininedeiminase and termed this drug ADI-PEG 20. ADI-PEG 20 appears to be an effective anti-cancer treatment for human HCC. Pharmacokinetic and pharmacodynamic data indicates a once a week injection of 160 IU/m2 of ADI-PEG 20 eliminates all detectable arginine from the circulation for at least 7 days. This treatment appears to be well tolerated. The purpose of this study is to determine the efficacy of this treatment in patients with HCC. Efficacy is a primary end point of this study. No patients will recieve placebo.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Polyethylene Glycol 3350

Condition Name

Condition Name for Polyethylene Glycol 3350
Intervention Trials
Constipation 21
Anemia 18
Colonoscopy 16
Healthy 9
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Condition MeSH

Condition MeSH for Polyethylene Glycol 3350
Intervention Trials
Constipation 27
Anemia 18
Hepatitis A 12
Hepatitis 12
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Clinical Trial Locations for Polyethylene Glycol 3350

Trials by Country

Trials by Country for Polyethylene Glycol 3350
Location Trials
United States 178
China 47
Italy 28
Spain 22
Canada 16
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Trials by US State

Trials by US State for Polyethylene Glycol 3350
Location Trials
Texas 13
New York 11
Pennsylvania 11
California 10
Maryland 10
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Clinical Trial Progress for Polyethylene Glycol 3350

Clinical Trial Phase

Clinical Trial Phase for Polyethylene Glycol 3350
Clinical Trial Phase Trials
Phase 4 72
Phase 3 43
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Polyethylene Glycol 3350
Clinical Trial Phase Trials
Completed 125
Recruiting 32
Not yet recruiting 22
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Clinical Trial Sponsors for Polyethylene Glycol 3350

Sponsor Name

Sponsor Name for Polyethylene Glycol 3350
Sponsor Trials
Hoffmann-La Roche 27
Jiangsu Hansoh Pharmaceutical Co., Ltd. 6
Queen's University 5
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Sponsor Type

Sponsor Type for Polyethylene Glycol 3350
Sponsor Trials
Other 219
Industry 102
NIH 10
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