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Last Updated: February 4, 2023

CLINICAL TRIALS PROFILE FOR CYSTEINE HYDROCHLORIDE


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505(b)(2) Clinical Trials for Cysteine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT01188096 ↗ A Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas Completed Emory University Phase 2 2010-08-01 This study is for patients up to 21 years of age who have a tumor called a low grade glioma of the central nervous system (brain and spinal cord). The tumor has grown despite attempts to control it with chemotherapy or radiation. Low grade gliomas are a group of tumors that tend to grow slowly and could be cured if every bit of the tumor were surgically removed. These tumors are called Grade I or II astrocytomas. These tumors often grow in parts of the brain that prevent total removal without devastating neurologic complications or death. Although some low grade gliomas never grow, most will and are treated with either chemotherapy or radiation. There is good data showing that the growth of most low grade gliomas can be controlled with chemotherapy or radiation. However, some low grade gliomas in children and young adults grow despite these treatments. Poly-ICLC is a new drug that has been used safely in children and adults with different types of brain tumors. Earlier studies showed that this drug worked better for children and young adults with low grade gliomas than for children with more aggressive brain tumors. The main purpose of this study is to use Poly-ICLC treatment in a larger number of patients to see how well it works and how many side effects occur. As Poly-ICLC is not FDA approved, this study is authorized to use it under IND# 43984, held by Oncovir. Subjects will get injections of Poly-ICLC into muscle two times weekly. The first treatments will be given in the clinic so allergic or other severe reactions, if any, can be monitored. If subjects tolerate the injections and don't have a severe reaction, then the rest of the injections will be given at home. Subjects/caregivers will be trained to give injections. Treatment will last for about 2 years. Subjects may stay on treatment for longer than 2 years if their tumor shrinks in response to the injections, if study doctors think it is safe, if subjects want to remain on treatment, and if Poly-ICLC is available. Risks: Poly-ICLC has been used safely in children and adults at the dose used in this study, and at higher doses. Frequently seen side effects include irritation of the skin at the injection site and mild flu-like symptoms. These are usually relieved or avoided by use of over-the-counter medicines like acetaminophen (Tylenol). Funding Source: FDA OOPD
OTC NCT01188096 ↗ A Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas Completed Donald Durden Phase 2 2010-08-01 This study is for patients up to 21 years of age who have a tumor called a low grade glioma of the central nervous system (brain and spinal cord). The tumor has grown despite attempts to control it with chemotherapy or radiation. Low grade gliomas are a group of tumors that tend to grow slowly and could be cured if every bit of the tumor were surgically removed. These tumors are called Grade I or II astrocytomas. These tumors often grow in parts of the brain that prevent total removal without devastating neurologic complications or death. Although some low grade gliomas never grow, most will and are treated with either chemotherapy or radiation. There is good data showing that the growth of most low grade gliomas can be controlled with chemotherapy or radiation. However, some low grade gliomas in children and young adults grow despite these treatments. Poly-ICLC is a new drug that has been used safely in children and adults with different types of brain tumors. Earlier studies showed that this drug worked better for children and young adults with low grade gliomas than for children with more aggressive brain tumors. The main purpose of this study is to use Poly-ICLC treatment in a larger number of patients to see how well it works and how many side effects occur. As Poly-ICLC is not FDA approved, this study is authorized to use it under IND# 43984, held by Oncovir. Subjects will get injections of Poly-ICLC into muscle two times weekly. The first treatments will be given in the clinic so allergic or other severe reactions, if any, can be monitored. If subjects tolerate the injections and don't have a severe reaction, then the rest of the injections will be given at home. Subjects/caregivers will be trained to give injections. Treatment will last for about 2 years. Subjects may stay on treatment for longer than 2 years if their tumor shrinks in response to the injections, if study doctors think it is safe, if subjects want to remain on treatment, and if Poly-ICLC is available. Risks: Poly-ICLC has been used safely in children and adults at the dose used in this study, and at higher doses. Frequently seen side effects include irritation of the skin at the injection site and mild flu-like symptoms. These are usually relieved or avoided by use of over-the-counter medicines like acetaminophen (Tylenol). Funding Source: FDA OOPD
OTC NCT01188096 ↗ A Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas Completed Donald Durden, M.D. Phase 2 2010-08-01 This study is for patients up to 21 years of age who have a tumor called a low grade glioma of the central nervous system (brain and spinal cord). The tumor has grown despite attempts to control it with chemotherapy or radiation. Low grade gliomas are a group of tumors that tend to grow slowly and could be cured if every bit of the tumor were surgically removed. These tumors are called Grade I or II astrocytomas. These tumors often grow in parts of the brain that prevent total removal without devastating neurologic complications or death. Although some low grade gliomas never grow, most will and are treated with either chemotherapy or radiation. There is good data showing that the growth of most low grade gliomas can be controlled with chemotherapy or radiation. However, some low grade gliomas in children and young adults grow despite these treatments. Poly-ICLC is a new drug that has been used safely in children and adults with different types of brain tumors. Earlier studies showed that this drug worked better for children and young adults with low grade gliomas than for children with more aggressive brain tumors. The main purpose of this study is to use Poly-ICLC treatment in a larger number of patients to see how well it works and how many side effects occur. As Poly-ICLC is not FDA approved, this study is authorized to use it under IND# 43984, held by Oncovir. Subjects will get injections of Poly-ICLC into muscle two times weekly. The first treatments will be given in the clinic so allergic or other severe reactions, if any, can be monitored. If subjects tolerate the injections and don't have a severe reaction, then the rest of the injections will be given at home. Subjects/caregivers will be trained to give injections. Treatment will last for about 2 years. Subjects may stay on treatment for longer than 2 years if their tumor shrinks in response to the injections, if study doctors think it is safe, if subjects want to remain on treatment, and if Poly-ICLC is available. Risks: Poly-ICLC has been used safely in children and adults at the dose used in this study, and at higher doses. Frequently seen side effects include irritation of the skin at the injection site and mild flu-like symptoms. These are usually relieved or avoided by use of over-the-counter medicines like acetaminophen (Tylenol). Funding Source: FDA OOPD
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Cysteine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000925 ↗ A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1999-05-01 The purpose of this study is to determine whether a high-quality protein food supplement will help HIV-positive patients maintain, and possibly gain, muscle mass. Many HIV-positive patients lose weight that they are then unable to regain. This may be because patients are not eating enough protein or are not eating the right kinds of protein. The protein eaten in foods (such as meat, eggs, or beans) may not be able to make up for the amount of protein lost due to HIV infection. This study gives patients high-quality protein food supplements to help them maintain and/or gain weight.
NCT00004831 ↗ Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria Completed St. Luke's-Roosevelt Hospital Center N/A 1996-10-01 OBJECTIVES: I. Determine the efficacy of cysteine hydrochloride in preventing or decreasing photosensitivity in patients with erythropoietic protoporphyria.
NCT00004831 ↗ Study of Cysteine Hydrochloride for Erythropoietic Protoporphyria Completed FDA Office of Orphan Products Development N/A 1996-10-01 OBJECTIVES: I. Determine the efficacy of cysteine hydrochloride in preventing or decreasing photosensitivity in patients with erythropoietic protoporphyria.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cysteine Hydrochloride

Condition Name

Condition Name for Cysteine Hydrochloride
Intervention Trials
Oxidative Stress 7
COVID-19 5
Autistic Disorder 4
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Condition MeSH

Condition MeSH for Cysteine Hydrochloride
Intervention Trials
Kidney Diseases 12
Diabetes Mellitus 8
Carcinoma 7
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Clinical Trial Locations for Cysteine Hydrochloride

Trials by Country

Trials by Country for Cysteine Hydrochloride
Location Trials
United States 272
China 12
Egypt 11
Australia 6
France 5
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Trials by US State

Trials by US State for Cysteine Hydrochloride
Location Trials
California 19
New York 15
Illinois 13
Florida 13
Ohio 12
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Clinical Trial Progress for Cysteine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Cysteine Hydrochloride
Clinical Trial Phase Trials
Phase 4 34
Phase 3 28
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Cysteine Hydrochloride
Clinical Trial Phase Trials
Completed 124
Unknown status 28
Not yet recruiting 25
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Clinical Trial Sponsors for Cysteine Hydrochloride

Sponsor Name

Sponsor Name for Cysteine Hydrochloride
Sponsor Trials
National Cancer Institute (NCI) 14
Ain Shams University 7
University of Chicago 6
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Sponsor Type

Sponsor Type for Cysteine Hydrochloride
Sponsor Trials
Other 294
Industry 46
NIH 31
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