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REP 2139-Ca / Pegasys™ Combination Therapy in Hepatitis B / Hepatitis D Co-infection
REP 2139-Ca / Pegasys™ Combination Therapy in Hepatitis B / Hepatitis D Co-infection
Purpose
REP 2139-Ca is nucleic acid polymer. Nucleic acid polymers have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV infected ducks) and in human patients and to act synergistically with immunotherapeutic agents such as pegylated interferon-alpha 2a or thymosin alpha-1 to restore host immunological control of HBV infection.
HBsAg is an essential component of the hepatitis D virus (HDV), therefore the direct action of REP 2139-Ca in removing serum HBsAg and its synergistic effect with pegylated interferon-alpha 2a is expected to have a significant antiviral effect against HDV infection.
This study will examine the safety and efficacy of REP 2139-Ca therapy when used in combination with pegylated interferon alpha-2a in patients with HBV / HDV co-infection.
The primary hypothesis to be tested is that this combined dosing regimen is safe and well tolerated in patients with HBV / HDV co-infection which will be assessed by examining the number of patients with adverse events (including reported symptoms and laboratory abnormalities).
The secondary hypothesis to be tested is that this combined dosing regimen will have an antiviral effect against HBV / HDV co-infection in these patients which will be assessed by examining the following outcomes:
The number of patients with reductions in serum HBsAg.
The number of patients with reductions in serum HDAg and HDV RNA
The number of patients that experience a sustained antiviral response after treatment is stopped (reductions in serum HBV DNA and HDV RNA).
The secondary hypothesis to be tested is that this combination approach can have an effective
Condition Intervention Phase
Hepatitis B With Hepatitis D Superinfection
Drug: REP 2139-Ca + Pegasys (TM)
Phase 2
Estimated Enrollment: 12
Study Start Date: September 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:
Nucleic acid polymers (NAPs) utilize the sequence independent properties of phosphorothioated oligonucleotides to target apolipoprotein interactions involved in the formation of HBV subviral particles (SVPs) which are comprised mainly of the hepatitis B surface antigen protein (HBsAg). The effect of NAPs is to block the formation of SVPs inside infected hepatocytes which prevents their secretion. As SVPs account for > 99.99% of HBsAg in the blood, NAPs are an effective approach for clearing HBsAg from the serum of HBV infected patient.
Previous clinical trials have demonstrated that treatment with the NAP REP 2139 results in the rapid and effective clearance of HBsAg from the blood. This HBsAg removal has the immediate effect of unmasking the underlying, pre-existing anti-HBsAg (anti-HBs) response, allowing clearance of HBV virus from the blood.
HBsAg has important immunosuppressive effects in HBV infection which have been shown to block both adaptive and innate immune processes. Removal of HBsAg from the blood of patients removes this immunosuppressive effect.
Thus, an important additional effect of removal of HBsAg from the blood is to greatly enhance the effect of immunotherapeutic agents like pegylated interferon alpha-2a or thymosin alpha-1 to stimulate recovery of complete immune control of HBV infection.
HDV superinfection can only occur in patients with HBV infection because HDV requires the HBsAg protein for its assembly. Therefore, it is expected that the removal of serum HBsAg (from HBV SVPs) and unmasking of the anticipated, pre-existing anti-HBsAg response by REP 2139 will result in the clearance of HBV and HDV from the blood. Furthermore, the enhanced effect of immunotherapy in the absence of serum HBsAg has the potential to provide a durable control of both HBV and HDV infection that will persist after treatment.
Locations
Moldova, Republic of
Infectious Clinical Hospital ( n.a. Toma Ciorba) Not yet recruiting
Chisinau, Moldova, Republic of, 2004
Contact: Victor Pantea, MD +373 69 37 11 27 ***@****
Contact: Valentin Cebotarescu, MD +373 79 50 51 46 valentin_cebotarescu***@****
Principal Investigator: Victor Pantea, MD
Sponsors and Collaborators
REPLICor Inc.
Purpose
REP 2139-Ca is nucleic acid polymer. Nucleic acid polymers have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV infected ducks) and in human patients and to act synergistically with immunotherapeutic agents such as pegylated interferon-alpha 2a or thymosin alpha-1 to restore host immunological control of HBV infection.
HBsAg is an essential component of the hepatitis D virus (HDV), therefore the direct action of REP 2139-Ca in removing serum HBsAg and its synergistic effect with pegylated interferon-alpha 2a is expected to have a significant antiviral effect against HDV infection.
This study will examine the safety and efficacy of REP 2139-Ca therapy when used in combination with pegylated interferon alpha-2a in patients with HBV / HDV co-infection.
The primary hypothesis to be tested is that this combined dosing regimen is safe and well tolerated in patients with HBV / HDV co-infection which will be assessed by examining the number of patients with adverse events (including reported symptoms and laboratory abnormalities).
The secondary hypothesis to be tested is that this combined dosing regimen will have an antiviral effect against HBV / HDV co-infection in these patients which will be assessed by examining the following outcomes:
The number of patients with reductions in serum HBsAg.
The number of patients with reductions in serum HDAg and HDV RNA
The number of patients that experience a sustained antiviral response after treatment is stopped (reductions in serum HBV DNA and HDV RNA).
The secondary hypothesis to be tested is that this combination approach can have an effective
Condition Intervention Phase
Hepatitis B With Hepatitis D Superinfection
Drug: REP 2139-Ca + Pegasys (TM)
Phase 2
Estimated Enrollment: 12
Study Start Date: September 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:
Nucleic acid polymers (NAPs) utilize the sequence independent properties of phosphorothioated oligonucleotides to target apolipoprotein interactions involved in the formation of HBV subviral particles (SVPs) which are comprised mainly of the hepatitis B surface antigen protein (HBsAg). The effect of NAPs is to block the formation of SVPs inside infected hepatocytes which prevents their secretion. As SVPs account for > 99.99% of HBsAg in the blood, NAPs are an effective approach for clearing HBsAg from the serum of HBV infected patient.
Previous clinical trials have demonstrated that treatment with the NAP REP 2139 results in the rapid and effective clearance of HBsAg from the blood. This HBsAg removal has the immediate effect of unmasking the underlying, pre-existing anti-HBsAg (anti-HBs) response, allowing clearance of HBV virus from the blood.
HBsAg has important immunosuppressive effects in HBV infection which have been shown to block both adaptive and innate immune processes. Removal of HBsAg from the blood of patients removes this immunosuppressive effect.
Thus, an important additional effect of removal of HBsAg from the blood is to greatly enhance the effect of immunotherapeutic agents like pegylated interferon alpha-2a or thymosin alpha-1 to stimulate recovery of complete immune control of HBV infection.
HDV superinfection can only occur in patients with HBV infection because HDV requires the HBsAg protein for its assembly. Therefore, it is expected that the removal of serum HBsAg (from HBV SVPs) and unmasking of the anticipated, pre-existing anti-HBsAg response by REP 2139 will result in the clearance of HBV and HDV from the blood. Furthermore, the enhanced effect of immunotherapy in the absence of serum HBsAg has the potential to provide a durable control of both HBV and HDV infection that will persist after treatment.
Locations
Moldova, Republic of
Infectious Clinical Hospital ( n.a. Toma Ciorba) Not yet recruiting
Chisinau, Moldova, Republic of, 2004
Contact: Victor Pantea, MD +373 69 37 11 27 ***@****
Contact: Valentin Cebotarescu, MD +373 79 50 51 46 valentin_cebotarescu***@****
Principal Investigator: Victor Pantea, MD
Sponsors and Collaborators
REPLICor Inc.
But previous empires including Roman and Greek and Egypt were just as similar.
Today in modern society we can phylosophicaly look at all this and try not to make the same mistakes. Yet powerful man still start wars on the weaker nations under any pretext. It is just with information age of today the powerful man - geo political blocks loose moral ground in doing what they are doing.
Us common folks have no beefs with each other. So if the tribal people have hbv cure ask to please help us. We have nothing to do with them loosing their land. The Royal family does.
Today in modern society we can phylosophicaly look at all this and try not to make the same mistakes. Yet powerful man still start wars on the weaker nations under any pretext. It is just with information age of today the powerful man - geo political blocks loose moral ground in doing what they are doing.
Us common folks have no beefs with each other. So if the tribal people have hbv cure ask to please help us. We have nothing to do with them loosing their land. The Royal family does.
If they know how to treat HBV they can make a world a better place. Common man in British Empire had very little to do with decision making the Royal family did to get wealthier.
But at the same time i agree with you that the British and westerners own reparations to native Americans and native people of Australia and New Zealand and south east asia for conquest and exploitation.
But at the same time i agree with you that the British and westerners own reparations to native Americans and native people of Australia and New Zealand and south east asia for conquest and exploitation.
Someone reading this may tell you that you have too many beers. It is not possible to give the land back to aboriginates or native american indians.
Besides you should tell your friend that human society is based on wars. And one civilization taking over the other. Human history is violent. Especially of those that are strong.
Besides you should tell your friend that human society is based on wars. And one civilization taking over the other. Human history is violent. Especially of those that are strong.
Also I'm only 60 years old and want to have more children do you think this will stop me?
Ok. So I haven't seen my neighbor but again but I had interesting chat with an aboriginal tribal elder over a barbeque with few beers and what he what he was explaining was Hepatitis b is all about global population control.
He also said when you think about a country like Australia with all its wealth if the original inhabitants the Aboriginals had control of their own wealth instead of having it stole from them over the years by others who came and stayed there then they would have invested in things like this. Nothing against people coming to visit Australia but shouldn't have been taking the Aboriginal wealth and not letting us have cure for these deadly diseases. I think I need to start a protest and it will be for give the Aboriginals their land back. I reckon they will help us if they get their land back. What does everyone else think?
He also said when you think about a country like Australia with all its wealth if the original inhabitants the Aboriginals had control of their own wealth instead of having it stole from them over the years by others who came and stayed there then they would have invested in things like this. Nothing against people coming to visit Australia but shouldn't have been taking the Aboriginal wealth and not letting us have cure for these deadly diseases. I think I need to start a protest and it will be for give the Aboriginals their land back. I reckon they will help us if they get their land back. What does everyone else think?
As with anything these days money buys you a new life.
Anyway. Stefan if you have link to the formula please pm or post here.
Anyway. Stefan if you have link to the formula please pm or post here.
Do you have a link.to that information? Because this is the first time I have heard it!
I dont understand. If i have the money, i can have the cure ? Where should someone go for it ?
the formula is public, we discussed this already years ago and some researcher helped us for price, formula and labs to have it done.no need for public funds who has about 50.000€ can have it done
I Doubt they give you the formula. If that was the case they would have already released the medication.
But very good idea you have. We can all donate funds. It is really what is needed an alternative pharma that makes medications that cure people. And funded by the people. So very good idea sir if you can make it.
But very good idea you have. We can all donate funds. It is really what is needed an alternative pharma that makes medications that cure people. And funded by the people. So very good idea sir if you can make it.
(Correction)
Let suppose we have a pharmaceutical labs and we are already manufacturing some medicine, tablets etc then can we make replicor medicine? how ? will they give us formula or something so that we can arrange our own trials, inn those countries having no strict rules or monopoly.
Let suppose we have a pharmaceutical labs and we are already manufacturing some medicine, tablets etc then can we make replicor medicine? how ? will they give us formula or something so that we can arrange our own trials, inn those countries having no strict rules or monopoly.
Let suppose we have a pharmaceutical labs and we are already manufacturing some medicine, tablets etc then can we make replicor medicine? how ? will they give us formula or something so that we can arrange our own trails, on those countries having no strict rules or monopoly.
you can have labs make it in israel, switzerland.there was a post some years ago about it, the cost would be about 50.000€
Can we manufacturer the REP 2139-Ca in Lab ? Like if i have some pharma labs are in my control then do they manufacture it even for trials ? or it's legally patented to Replicor company only.
how to know the formula or procedure ? If anybody have such info then please share.
how to know the formula or procedure ? If anybody have such info then please share.
I'll ask them when I next see them.
I will go an see some Aboriginal tribal elders later I will ask them to if they know anything..
Do you remember strawberry season? I remember strawberry season. Don't you notice the way strawberries are available all year round now?
I will go an see some Aboriginal tribal elders later I will ask them to if they know anything..
Do you remember strawberry season? I remember strawberry season. Don't you notice the way strawberries are available all year round now?
http://books.google.com/books?id=ZAuZbbQGbicC&pg=PA173&lpg=PA173&dq=olive+leaf+kills+hepatitis+B&source=bl&ots=FywIlKtfp-&sig=TBmElJQv8E_HHpNsiFEt0WroQjg&hl=en&sa=X&ei=AdYVVI7NL43koATG2IH4Bg&ved=0CFgQ6AEwBg#v=onepage&q=olive%20leaf%20kills%20hepatitis%20B&f=false
http://www.candida-diet-center.net/olive-leaf-extract.html
Good info on olive leaf...
Good info on olive leaf...
that is interesting. How did your neighbor got the info? Can you be more specific please.
you have to know that moldova is the poorest country in Europe. Moldova is trying hard to join european union, that's why romania erased the visa request for them, now they have free way to europe through romania. Moldova is somehow in the middle between romania and transnistria's influences from the soviet union, but for the health system, perhaps its not that corrupt, being such a poor country, i dont think the influence of coruption got them yet. I will try and find out more
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