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HSV-2 Phase 2 Trial May commence soon in Taiwan

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Pokemon
2 hours ago, moialbalushi said:

Page not found bro !! Can you tell us whats there plz ? 

I clicked on the link and it came up. Here are the details:

NCT03595995: An ongoing trial by United BioPharma

This trial is ongoing. It must report results 3 years, 2 months from now.

Full data

Full entry on ClinicalTrials.gov NCT03595995
Title A Randomized, Double-blind, Dose-ranging, Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621 on HSV Shedding in Adults With Recurrent Genital HSV-2 Infection.
Results Status Ongoing
ACT or pACT? This is what FDAAA officially calls an "Applicable Clinical Trial"
Start date Feb. 1, 2019
Completion date Dec. 31, 2020
Required reporting date Dec. 31, 2021, midnight
Actual reporting date None
Date last checked at ClinicalTrials.gov Oct. 15, 2018
Days late None

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Pokemon

More details at: https://clinicaltrials.gov/ct2/show/NCT03595995

Eligibility Criteria
 
Go to  sections
 

 

Information from the National Library of MedicineNIH_NLM_ABRV_BLK_4.png

 

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

 
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be HSV-2 seropositive
  • Subjects have a history of recurrent genital herpes in the past year
  • Subjects have a negative result on the HIV Ab/Ag assay
  • Subjects must agree to use contraception during study participation

Exclusion Criteria:

  • Documented HSV resistance to acyclovir, valacyclovir, famciclovir, or penciclovir
  • History or current evidence of malignancy except for a localized non-melanoma skin cancer
  • Known immunosuppression
  • Exposure to HSV vaccine
  • Medical history of macular or maculopapular skin reactions to antibody (ie, as evidenced by IgG or plasma administration)
  • Any other conditions that in the judgment of the Investigator would preclude successful completion of the clinical study

Contacts and Locations
 
Go to  sections
 
Information from the National Library of MedicineNIH_NLM_ABRV_BLK_4.png

 

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595995

 
Contacts
       
Contact: Jessica Cheng +886-3-668-4800 ext 3613 jessica.cheng@unitedbiopharma.com  
Contact: Annie Lai +886-3-668-4800 ext 3614 annie.lai@unitedbiopharma.com  

Sponsors and Collaborators
United BioPharma
More Information
 
Go to  sections
 
   
Responsible Party: United BioPharma
ClinicalTrials.gov Identifier: NCT03595995     History of Changes
Other Study ID Numbers: UBP-A206-HSV 
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
 
Additional relevant MeSH terms:
   
Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female

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Pokemon
 
 Save this study
 

A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621 in Adults With Recurrent Genital HSV-2 Infection.

warning.png The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03595995
Recruitment Status : Not yet recruiting
First Posted : July 23, 2018
Last Update Posted : August 14, 2018
Sponsor:
United BioPharma
Information provided by (Responsible Party):
United BioPharma
 
Study Description
 
Go to  sections
Brief Summary:
To evaluate the efficacy of two dose levels of UB-621 administration in reducing the HSV-2 genital shedding rate in patients with recurrent genital HSV-2 infection.
 
Condition or disease  Intervention/treatment  Phase 
Genital Herpes Biological: UB-621Other: Placebo Phase 2

Study Design
 
Go to  sections

 

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Dose-ranging, Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621 on HSV Shedding in Adults With Recurrent Genital HSV-2 Infection.
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

 

Resource links provided by the National Library of MedicineNIH_NLM_ABRV_BLK_4.png

 

 

MedlinePlus related topics: Genital Herpes
Arms and Interventions
 
Go to  sections

 

Arm  Intervention/treatment 
Experimental: Cohort 1 Biological: UB-621
Monoclonal antibody by SC injection

Other: Placebo
The placebo is a sterile, clear and colorless or slightly yellow liquid, contains the same composition as UB-621 except drug substance. It is given by SC injection.
Experimental: Cohort 2 Biological: UB-621
Monoclonal antibody by SC injection

Other: Placebo
The placebo is a sterile, clear and colorless or slightly yellow liquid, contains the same composition as UB-621 except drug substance. It is given by SC injection.
 
Outcome Measures
 
Go to  sections
 
Primary Outcome Measures :
  1. The change of HSV-2 shedding rate [ Time Frame: 112 days ]
 
Secondary Outcome Measures :
  1. The change of HSV-2 viral load [ Time Frame: 112 days ]
  2. The change of genital lesion rates [ Time Frame: 196 days ]

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Little Star

So what is this a shot or tablets?

I wish someone would hurry the fuck up and just find a fucking cure!

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Pokemon
12 minutes ago, Little Star said:

So what is this a shot or tablets?

It says: "Monoclonal antibody by SC injection", so it's a shot.

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Little Star
1 minute ago, Pokemon said:

It says: "Monoclonal antibody by SC injection", so it's a shot.

Cool!

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valleynovascotia
30 minutes ago, Little Star said:

So what is this a shot or tablets?

I wish someone would hurry the fuck up and just find a fucking cure!

I agree life is passing me by i'm losing  opportunities with women that i'll never get again. 

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Fadela

I sent off an email. Was told if interested in trials to get in touch for next June. FYI just so we aren’t bombarding with emails ☺️

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Little Star
6 hours ago, Fadela said:

I sent off an email. Was told if interested in trials to get in touch for next June. FYI just so we aren’t bombarding with emails ☺️

Great news!

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Little Star

Let’s hope this is one.

Lets hope this gives us the cure we so desperately need.

Fingers crossed everyone :sunny::heart:

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ill47

Its not a cure, it's an antibody therapeutic treatment ( I think). Still important and valuable. It looks like they did not release Phase 1 results, but if it is going to phase 2 they must have at least shown some promise. 

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moialbalushi
8 hours ago, Fadela said:

I sent off an email. Was told if interested in trials to get in touch for next June. FYI just so we aren’t bombarding with emails ☺️

Plz let us know

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MikeHerp

This kind of treatment hasn't been tried for herpes, as far as I know (but I could be wrong), so it will be interesting what they find.  

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Holy Hope

That gives me hope! Does anyone know the locations of they are recruiting at? I'm in Canada and wish we have more research here.

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RNY18

I wrote to them and received this reply :

“..Thank you for your inquiry. 

This study is still under regulator’s reviewing, once approved by FDA, we will change the status to “recruiting” on clinicaltrials.gov and release the hospital name to public.  

 

Best Regards,

Annie

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MikeHerp
5 hours ago, RNY18 said:

I wrote to them and received this reply :

“..Thank you for your inquiry. 

This study is still under regulator’s reviewing, once approved by FDA, we will change the status to “recruiting” on clinicaltrials.gov and release the hospital name to public.  

 

Best Regards,

Annie

good to know 

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Api8519

Hai .. Im new here... I think if that vaccine is a new hope , or even can cure hsv, i think the FDA will not approve it, because the FDA get a lot of money from the antiviral med... They will not let hsv cure to public, i hope i wrong on my oppinion...

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